Recall archive / FDA device enforcement
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-01... — FDA record Z-2172-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2095802-001-554923, 9) 2095802-001-554924, 10) 2095802-001-554925, 11) 2095802-001-554926, 12) 2095802-001-554927, 13) 2095802-001-554928, 14) 2095802-001-555120, 15) 2095802-001-556223, 16) 2095802-001-557346, 17) 2095802-001-558678, 18) 2095802-001-558707, 19) 2095802-001-559208, 20) 2095802-001-559337, 21) 2095802-001-559916, 22) 2095802-001-560446, 23) 2095802-001-560519, 24) 2095802-001-560520, 25) 2095802-001-560521, 26) 2095802-001-560522, 27) 2095802-001-560637, 28) 2095802-001-560803, 29) 2095802-001-561557, 30) 2095802-001-562090, 31) 2095802-001-562136, 32) 2095802-001-562249, 33) 2095802-001-562799, 34) 2095802-001-563317, 35) 2095802-001-563770, 36) 2095802-001-563771, 37) 2095802-001-564033, 38) 2095802-001-564174, 39) 2095802-001-565603, 40) 2095802-001-566307, 41) 2095802-001-566308, 42) 2095802-001-566696, 43) 2095802-001-566798, 44) 2095802-001-566816, 45) 2095802-001-566825, 46) 2095802-001-566826, 47) 2095802-001-566925, 48) 2095802-001-567844, 49) 2095802-001-568125, 50) 2095802-001-568726, 51) 2095802-001-568765, 52) 2095802-001-569226, 53) 2095802-001-569235, 54) 2095802-001-569318, 55) 2095802-001-569322, 56) 2095802-001-569329, 57) 2095802-001-569332, 58) 2095802-001-569426, 59) 2095802-001-569860, 60) 2095802-001-569871, 61) 2095802-001-569990, 62) 2095802-001-570062, 63) 2095802-001-570185, 64) 2095802-001-570746, 65) 2095802-001-570960, 66) 2095802-001-571048, 67) 2095802-001-571049, 68) 2095802-001-571801, 69) 2095802-001-571807, 70) 2095802-001-572988, 71) 2095802-001-572991, 72) 2095802-001-573205, 73) 2095802-001-574167, 74) 2095802-001-574403, 75) 2095802-001-574569, 76) 2095802-001-574570, 77) 2095802-001-574685, 78) 2095802-001-575604, 79) 2095802-001-575842, 80) 2095802-001-576569, 81) 2095802-001-577254, 82) 2095802-001-577260, 83) 2095802-001-577472, 84) 2095802-001-577688, 85) 2095802-001-578467, 86) 2095802-001-578468, 87) 2095802-001-579029, 88) 2095802-001-579134, 89) 2095802-001-579366, 90) 2095802-001-579526, 91) 2095802-001-579590, 92) 2095802-001-579604, 93) 2095802-001-579692, 94) 2095802-001-579926, 95) 2095802-001-579933, 96) 2095802-001-580487, 97) 2095802-001-580731, 98) 2095802-001-581010, 99) 2095802-001-581094, 100) 2095802-001-581417, 101) 2095802-001-581433, 102) 2095802-001-582510, 103) 2095802-001-582710, 104) 2095802-001-582906, 105) 2095802-001-582907, 106) 2095802-001-583150, 107) 2095802-001-583551, 108) 2095802-001-583553, 109) 2095802-001-583888, 110) 2095802-001-583970, 111) 2095802-001-584288, 112) 2095802-001-584547, 113) 2095802-001-584810, 114) 2095802-001-585047, 115) 2095802-001-585468, 116) 2095802-001-585907, 117) 2095802-001-586028, 118) 2095802-001-586829, 119) 2095802-001-587286, 120) 2095802-001-587726, 121) 2095802-001-587767, 122) 2095802-001-587770, 123) 2095802-001-588006, 124) 20...
- Reason
- GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
- Classification
- Class II
- Recalling firm
- GE Healthcare Finland Oy
- Quantity
- 25268 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2172-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) model MBC303: 1) 2078633-001, UDI/DI none, Serial Numbers: 2293663-1-1; 2) 2078633-010, UDI/DI none, Serial Numbers: 2284163-2-1, 2284112-3-1, 2284163-1-1, 2284112-4-1, 2262484-1-1, 2262484-1-2; 3) 2078633-012, UDI/DI none, Serial Numbers: 2400553-4-1, 2266860-3-2; 4) 2078633-017, UDI/DI none, Serial Numbers: 2261264-2-1, 2290421-2-1, 2288663-1-1, 2290422-2-1, 2312000-3-1, 2311672-4-1, 2311672-5-1, 2320320-1-1, 2284038-3-1, 2329280-2-1; 5) 2078633-028, UDI/DI none, Serial Numbers: 2426418-2-1, 2450634-2-1, 2501447-2-1, 2426426-25-1, 2428347-1-1, 2460598-2-1, 2405070-10-1, 2426421-3-1, 2460618-6-1, 2583610-13-1, 2426425-5-1, 2428332-1-1, 2428345-1-1, 2460628-7-1, 2403419-9-1, 2426423-4-1, 2501439-13-1, 2409922-12-1, 2423627-1-1, 2460617-1-1, 2501399-4-1, 2501446-13-1, 2445364-1-1, 2465141-1-1; 6) 2095802-001-54069330, UDI/DI 00840682136723, Serial Numbers: SNR19110001HA, SNR19110005HA, SNR19110002HA, SNR19110003HA, SNR19110004HA; 7) 2095802-001-554922, UDI/DI 00840682136723, Serial Numbers: SNR18060001HA, SNR18060003HA, SNR18060005HA, SNR18060006HA, SNR18060007HA, SNR18060012HA, SNR18060013HA, SNR18060014HA, SNR18060015HA, SNR18060016HA, SNR18060017HA, SNR18010010HA, SNR18010012HA, SNR18010021HA; 8) 2095802-001-554923, UDI/DI 00840682136723, Serial Numbers: SNR18060011HA, SNR18060022HA, SNR18060028HA, SNR18060029HA, SNR18060031HA, SNR18060032HA, SNR18060036HA, SNR18070001HA, SNR18070003HA, SNR18070008HA, SNR18070012HA, SNR18070013HA, SNR18070014HA, SNR18070018HA, SNR18070019HA, SNR18070020HA, SNR18070021HA, SNR18070022HA, SNR18070023HA, SNR18070024HA, SNR18070025HA, SNR18070026HA, SNR18070027HA, SNR18070028HA, SNR18070029HA, SNR18070030HA, SNR18070031HA, SNR18070032HA, SNR18070033HA, SNR18070037HA, SNR18070038HA, SNR18070039HA, SNR18070040HA, SNR18070045HA, SNR18070046HA, SNR18070052HA, SNR19030080HA, SNR19030081HA, SNR19030082HA, SNR19030083HA, SNR19030084HA, SNR19030091HA, SNR19040002HA, SNR19040003HA, SNR19040004HA, SNR19040005HA, SNR19040006HA, SNR19040007HA, SNR18070007HA, SNR18080007HA, SNR18370013HA, SNR18070016HA, SNR18070017HA, SNR19030085HA; 9) 2095802-001-554924, UDI/DI 00840682136723, Serial Numbers: SNR18010004HA, SNR18010011HA, SNR18020001HA; 10) 2095802-001-554925, UDI/DI 00840682136723, Serial Numbers: SNR18070076HA, SNR18070077HA, SNR18070078HA, SNR18070079HA, SNR18070080HA, SNR18070081HA, SNR18070082HA, SNR18070083HA, SNR18070084HA, SNR18070085HA, SNR18070086HA, SNR18070089HA, SNR18070090HA, SNR18080001HA, SNR18080002HA, SNR18080003HA, SNR18390025HA, SNR18390027HA, SNR18400032HA, SNR18400033HA, SNR18400035HA, SNR18400037HA, SNR18400045HA, SNR18400046HA, SNR18400047HA, SNR18400053HA, SNR18400066HA, SNR19190046HA, SNR19190047HA, SNR19190048HA, SNR19190049HA, SNR19190050HA, SNR19190051HA, SNR19190052HA, SNR19190053HA, SNR18010001HA, SNR18010003HA, SNR18010013HA, SNR18010014HA, SNR18010020HA, SNR18010028HA, SNR18010029HA, SNR18020002HA; 11) 2095802-001-554926, UDI/DI 00840682136723, Serial Numbers: SNR18060002HA, SNR18060008HA, SNR18060009HA, SNR18060010HA, SNR18060018HA, SNR18060019HA, SNR18060020HA, SNR18060021HA, SNR18060023HA, SNR18060024HA, SNR18060025HA, SNR18060026HA, SNR18060027HA, SNR18060030HA, SNR18060033HA, SNR18060034HA, SNR18060035HA, SNR18070002HA, SNR18070005HA, SNR18070006HA, SNR18070009HA, SNR18070010HA, SNR18070011HA, SNR19030086HA, SNR19030087HA, SNR19030088HA, SNR19030089HA, SNR19030090HA, SNR19030092HA, SNR19030093HA, SNR19030094HA, SNR19030095HA, SNR19030096HA, SNR19030097HA, SNR19030098HA, SNR19030099HA, SNR19030100HA, SNR19030101HA, SNR19030102HA, SNR19030103HA, SNR19040019HA, SNR19040037HA, SNR19040038HA, SNR19040039HA, SNR19040050HA, SNR19040051HA, SNR18010002HA, SNR18010005HA, SNR18010009HA, SNR18010018HA, SNR18010027HA; 12) 2095802-001-554927, UDI/DI 00840682136723, Serial Numbers: SNR18010006HA, SNR18010023HA, SNR18010024HA, SNR18010025HA, SNR18010026HA, SNR18010016HA; 13) 2095802-001-554928, UDI/DI 00840682136723, Serial Numbers: SNR18070041HA, SNR18070042HA, SNR18070043HA, SNR18070044HA, SNR18070047HA, SNR18070048HA, SNR18070064HA, SNR18070065HA, SNR18070066HA, SNR18070067HA, SNR18070068HA, SNR18070073HA, SNR18070074HA, SNR18070075HA, SNR18080004HA, SNR18080005HA, SNR18160046HA, SNR18180021HA, SNR18380012HA; 14) 2095802-001-555120, UDI/DI 00840682136723, Serial Numbers: SNR18070015HA, SNR18070035HA, SNR18070036HA, SNR18070049HA, SNR18070050HA, SNR18070054HA, SNR18070055HA, SNR18070056HA, SNR18070057HA, SNR18070060HA, SNR18070087HA, SNR18070091HA; 15) 2095802-001-556223, UDI/DI 00840682136723, Serial Numbers: SNR18180048HA, SNR18330090HA, SNR18360020HA, SNR18360025HA, SNR18360026HA, SNR18360055HA, SNR18360021HA, SNR18360023HA, SNR18070069HA, SNR18070070HA, SNR18070071HA, SNR18070072HA; 16) 2095802-001-557346, UDI/DI 00840682136723, Serial Numbers: SNR18010017HA; 17) 2095802-001-558678, UDI/DI 00840682136723, Serial Numbers: SNR18010030HA, SNR18010019HA, SNR18100006HA, SNR18100007HA, SNR18180040HA, SNR18180041HA, SNR18180044HA, SNR18180047HA, SNR18180049HA, SNR18190004HA, SNR18190007HA, SNR18010015HA; 18) 2095802-001-558707, UDI/DI 00840682136723, Serial Numbers: SNR18080010HA, SNR18080028HA, SNR18100005HA; 19) 2095802-001-559208, UDI/DI 00840682136723, Serial Numbers: SNR18080018HA, SNR18080012HA, SNR18080011HA; 20) 2095802-001-559337, UDI/DI 00840682136723, Serial Numbers: SNR18080014HA, SNR18080024HA, SNR18080008HA, SNR18080013HA, SNR18080015HA; 21) 2095802-001-559916, UDI/DI 00840682136723, Serial Numbers: SNR18060004HA, SNR18070004HA, SNR18070034HA, SNR18070051HA, SNR18070053HA, SNR18070058HA, SNR18070059HA, SNR18070061HA, SNR18070062HA, SNR18070063HA, SNR18080006HA, SNR18080009HA, SNR18080016HA, SNR18080019HA, SNR18080020HA, SNR18080022HA, SNR18080023HA, SNR18080025HA; 22) 2095802-001-560446, UDI/DI 00840682136723, Serial Numbers: SNR18160008HA, SNR18160009HA, SNR18160015HA, SNR18160016HA, SNR18160017HA, SNR18160018HA, SNR18160020HA, SNR18160021HA, SNR18160022HA; 23) 2095802-001-560519, UDI/DI 00840682136723, Serial Numbers: SNR18160005HA, SNR18160006HA, SNR18160010HA, SNR18160011HA, SNR18160012HA, SNR18160013HA, SNR18160042HA, SNR18160050HA; 24) 2095802-001-560520, UDI/DI 00840682136723, Serial Numbers: SNR18150029HA, SNR18150033HA, SNR18150035HA, SNR18150039HA, SNR18160023HA, SNR18160024HA, SNR18160025HA, SNR18160026HA, SNR18160027HA, SNR18160029HA, SNR18160030HA, SNR18160031HA, SNR18160034HA, SNR18160038HA, SNR18160039HA, SNR18160041HA, SNR18160047HA, SNR18160056HA, SNR18160057HA, SNR18160059HA, SNR18160060HA, SNR18160063HA, SNR18160066HA; 25) 2095802-001-560521, UDI/DI 00840682136723, Serial Numbers: SNR18150027HA, SNR18150031HA, SNR18150032HA, SNR18150034HA, SNR18150037HA, SNR18150038HA, SNR18150040HA, SNR18160001HA, SNR18160014HA, SNR18160019HA, SNR18160043HA, SNR18160048HA; 26) 2095802-001-560522, UDI/DI 00840682136723, Serial Numbers: SNR18160032HA, SNR18160036HA, SNR18160037HA, SNR18160040HA, SNR18160065HA; 27) 2095802-001-560637, UDI/DI 00840682136723, Serial Numbers: SNR18080027HA, SNR18080017HA; 28) 2095802-001-560803, UDI/DI 00840682136723, Serial Numbers: SNR18080021HA, SNR18100004HA, SNR18100001HA, SNR18100003HA, SNR18080029HA; 29) 2095802-001-561557, UDI/DI 00840682136723, Serial Numbers: SNR18100008HA, SNR18150001HA, SNR18150002HA, SNR18150003HA, SNR18150005HA, SNR18150006HA, SNR18150007HA, SNR18150008HA, SNR18150009HA, SNR18150012HA, SNR18150014HA, SNR18150015HA, SNR18150016HA, SNR18150017HA, SNR18150018HA, SNR18150019HA, SNR18150021HA, SNR18150022HA, SNR18150023HA, SNR18150024HA, SNR18150025HA, SNR18010007HA, SNR18010008HA, SNR18010022HA; 30) 2095802-001-562090, UDI/DI 00840682136723, Serial Numbers: SNR18360015HA, SNR18360043HA, SNR18360058HA; 31) 2095802-001-562136, UDI/DI 00840682136723, Serial Numbers: SNR18080026HA, SNR18080030HA, SNR18100002HA; 32) 2095802-001-562249, UDI/DI 00840682136723, Serial Numbers: SNR18150020HA, SNR18150026HA; 33) 2095802-001-562799, UDI/DI 00840682136723, Serial Numbers: SNR18380008HA, SNR18380010HA; 34) 2095802-001-563317, UDI/DI 00840682136723, Serial Numbers: SNR18160033HA; 35) 2095802-001-563770, UDI/DI 00840682136723, Serial Numbers: SNR18180061HA, SNR18190006HA, SNR18190034HA, SNR18200034HA; 36) 2095802-001-563771, UDI/DI 00840682136723, Serial Numbers: SNR18180001HA; 37) 2095802-001-564033, UDI/DI 00840682136723, Serial Numbers: SNR18300002SA, SNR18300017SA, SNR18300019SA, SNR18300025SA; 38) 2095802-001-564174, UDI/DI 00840682136723, Serial Numbers: SNR18160028HA; 39) 2095802-001-565603, UDI/DI 00840682136723, Serial Numbers: SNR18150028HA, SNR18360019HA; 40) 2095802-001-566307, UDI/DI 00840682136723, Serial Numbers: SNR18150004HA, SNR18150011HA, SNR18150030HA, SNR18150036HA, SNR18200018HA; 41) 2095802-001-566308, UDI/DI 00840682136723, Serial Numbers: SNR18160004HA, SNR18160035HA, SNR18160045HA, SNR18160049HA, SNR18160054HA, SNR18160061HA, SNR18160067HA, SNR18170001HA, SNR18180013HA, SNR18180014HA, SNR18180019HA, SNR18180050HA, SNR18200011HA; 42) 2095802-001-566696, UDI/DI 00840682136723, Serial Numbers: SNR18180043HA, SNR18180045HA, SNR18180054HA, SNR18180055HA, SNR18180056HA, SNR18180057HA, SNR18180058HA, SNR18180059HA, SNR18190002HA, SNR18190005HA, SNR18190008HA, SNR18190009HA, SNR18190011HA, SNR18190012HA, SNR18190013HA, SNR18190014HA, SNR18190016HA, SNR18190017HA, SNR18190018HA, SNR18190019HA, SNR18190020HA, SNR18190021HA, SNR18190022HA, SNR18190023HA, SNR18190024HA, SNR18190025HA, SNR18190026HA, SNR18190027HA, SNR18190028HA, SNR18190029HA, SNR18190030HA, SNR18190031HA, SNR18190032HA, SNR18190035HA, SNR18190036HA, SNR18190037HA, SNR18190038HA, SNR18190039HA, SNR18190040HA, SNR18190043HA, SNR18190044HA, SNR18190045HA, SNR18200001HA, SNR18200003HA, SNR18200006HA, SNR18200007HA, SNR18200009HA, SNR18200010HA, SNR18200012HA, SNR18200014HA, SNR18200017HA, SNR18200021HA, SNR18200022HA, SNR18200023HA, SNR18200024HA, SNR18200025HA, SNR18200026HA, SNR18200028HA, SNR18200029HA, SNR18200030HA, SNR18200031HA, SNR18200032HA, SNR18200033HA, SNR18200037HA, SNR18200038HA, SNR18200039HA, SNR18200040HA, SNR18200041HA, SNR18200042HA, SNR18200043HA, SNR18200044HA, SNR18200045HA, SNR18200046HA, SNR18200047HA, SNR18200048HA; 43) 2095802-001-566798, UDI/DI 00840682136723, Serial Numbers: SNR18190033HA, SNR18200002HA, SNR18200004HA, SNR18200005HA, SNR18200008HA, SNR18200013HA, SNR18200020HA, SNR18200027HA, SNR18200055HA, SNR18310012HA, SNR18310017HA, SNR18310019HA, SNR18310021HA, SNR18310023HA, SNR18310024HA, SNR18320002HA, SNR18320004HA, SNR18320005HA, SNR18320007HA, SNR18320008HA, SNR19170069HA; 44) 2095802-001-566816, UDI/DI 00840682136723, Serial Numbers: SNR18150013HA, SNR18180035HA, SNR18180037HA, SNR18390023HA, SNR18390024HA, SNR18390026HA, SNR18390028HA, SNR18390029HA, SNR18390030HA, SNR18390032HA, SNR18390033HA, SNR18390035HA, SNR18390036HA, SNR18390038HA, SNR18390039HA, SNR18390041HA, SNR18390042HA, SNR18390043HA, SNR18390045HA, SNR18390047HA, SNR18390049HA, SNR18400003HA, SNR18400004HA, SNR18400006HA, SNR18400025HA, SNR18400042HA, SNR18400048HA, SNR18400050HA, SNR18400051HA, SNR18400052HA, SNR18400054HA, SNR18400055HA, SNR18400056HA, SNR18400057HA, SNR18400058HA, SNR18400059HA, SNR18400060HA, SNR18400061HA, SNR18400062HA, SNR18400064HA, SNR18400065HA, SNR18440032HA, SNR19030044HA; 45) 2095802-001-566825, UDI/DI 00840682136723, Serial Numbers: SNR18160002HA, SNR18160052HA, SNR18160053HA, SNR18160055HA, SNR18160058HA, SNR18180015HA, SNR18180016HA, SNR18180017HA, SNR18190010HA, SNR18200016HA; 46) 2095802-001-566826, UDI/DI 00840682136723, Serial Numbers: SNR18150010HA, SNR18160051HA; 47) 2095802-001-566925, UDI/DI 00840682136723, Serial Numbers: SNR18330028HA, SNR18330031HA, SNR18330047HA, SNR18330049HA, SNR18330052HA, SNR18330056HA, SNR18330061HA, SNR18330065HA, SNR18330071HA, SNR18330081HA, SNR18330083HA, SNR18330086HA, SNR18330089HA, SNR18330091HA, SNR18330093HA, SNR18330094HA; 48) 2095802-001-567844, UDI/DI 00840682136723, Serial Numbers: SNR18180002HA, SNR18180005HA, SNR18180006HA, SNR18180007HA, SNR18180008HA, SNR18180009HA, SNR18180018HA, SNR18180020HA, SNR18180... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 3, 2024
- Recall initiation date
- Apr 5, 2024
- Center classification date
- Jun 21, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.