Recall archive / FDA device enforcement
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-P... — FDA record Z-2622-2025
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 Aug 15, 2025. 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
- BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
- Reason
- Potential for activation of an abnormal alarm pause.
- Classification
- Class II
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 2,278 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2622-2025
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 | Below configurations of the Benevision N1 patient monitor (UDI-DI: 06944904094922) with software version versions 01.04.00.01, 01.05.00.01, 01.06.00.01, 01.06.01.01: 1. N1 Nellcor: Part Number: 6660E-PA00010; Serial Numbers: AA3-06023768, AA3-06023476, AA3-03014849. 2. Used N1 Nellcor: Part Number: Q6660E-PA00010; Serial Numbers: AA3-8C003924. 3. N1 Nellcor, ST: Part Number: 6660E-PA00011; Serial Numbers: AA3-92004799, AA3-06023994, AA3-03014853, AA3-03014857, AA3-03014701, AA3-03014714, AA3-03014848, AA3-03014850, AA3-03014861, AA3-03014865, AA3-04017814, AA3-06024001, AA3-03014700, AA3-03014702, AA3-03014703, AA3-03014705, AA3-03014707, AA3-03014710, AA3-03014854, AA3-03014859, AA3-03014862, AA3-03014864, AA3-03014867, AA3-9C011900, AA3-9C011901, AA3-9C011905, AA3-9C011916, AA3-9C011918, AA3-9C011920, AA3-02013653, AA3-02013654, AA3-02013655, AA3-02013656, AA3-02013657, AA3-07024289, AA3-94006408, AA3-97007795, AA3-98008764, AA3-98008766, AA3-98008774, AA3-98008789, AA3-98008799, AA3-98008801, AA3-98008802, AA3-9C011260, AA3-9C011240, AA3-9C011242, AA3-9C011249, AA3-9C011259, AA3-03014712, AA3-05021468, AA3-97007785, AA3-97007786, AA3-97007787, AA3-97007788, AA3-97007789, AA3-97007790, AA3-97007791, AA3-97007792, AA3-97007794, AA3-97007796, AA3-97007797, AA3-97007798, AA3-97007799, AA3-97007800, AA3-97007801, AA3-97007802, AA3-97007803, AA3-97007804, AA3-97007805, AA3-97007806, AA3-97007808, AA3-97007809, AA3-97007810, AA3-97007811, AA3-97007812, AA3-97007813, AA3-97007814, AA3-97007815, AA3-97007816, AA3-97007817, AA3-97007818, AA3-97007819, AA3-97007821, AA3-97007822, AA3-97007823, AA3-97007824, AA3-97007825, AA3-97007826, AA3-97007827, AA3-97007828, AA3-97007829, AA3-98008767, AA3-98008772, AA3-98008773, AA3-98008806, AA3-98008807, AA3-98008808, AA3-98008809, AA3-98008810, AA3-98008811, AA3-98008812, AA3-98008813, AA3-98008814, AA3-98008816, AA3-98008817, AA3-98008818, AA3-98008819, AA3-98008821, AA3-98008822, AA3-98008823, AA3-98008824, AA3-98008825, AA3-98008985, AA3-98008986, AA3-98008987, AA3-98008988, AA3-98008989, AA3-98008990, AA3-98008991, AA3-98008993, AA3-98008994, AA3-98008995, AA3-98008996, AA3-98008997, AA3-98008998, AA3-98008999, AA3-98009000, AA3-98009001, AA3-98009002, AA3-98009003, AA3-98009004, AA3-98009106, AA3-98009109, AA3-9C011896, AA3-9C011910, AA3-9C011914, AA3-98009110, AA3-98009117, AA3-98009120, AA3-07024284, AA3-07024306, AA3-06024000, AA3-05020241, AA3-05020250, AA3-05021448, AA3-9C011915, AA3-9C011919, AA3-94006405, AA3-94006407, AA3-94006598, AA3-94006599, AA3-94006600, AA3-94006601, AA3-07024268, AA3-07024285, AA3-07024287, AA3-07024295, AA3-07024301, AA3-07024302, AA3-03014869, AA3-92004800, AA3-94006409, AA3-94006415, AA3-98008763, AA3-98008769, AA3-98008775, AA3-98008777, AA3-98008783, AA3-98008784, AA3-98008785, AA3-98008791, AA3-98008796, AA3-9C011244, AA3-07024292, AA3-05021350, AA3-05021353, AA3-05021356, AA3-05021440, AA3-06023481, AA3-06023489, AA3-06023495, AA3-06024075, AA3-06023765, AA3-06024045, AA3-06024047, AA3-07024293, AA3-07024303, AA3-03014855, AA3-03014856, AA3-03014858, AA3-03014863, AA3-03014866, AA3-03014868, AA3-07024307, AA3-06024007, AA3-07024263, AA3-92004801, AA3-94005815, AA3-94006402, AA3-94006410, AA3-98009103, AA3-98009104, AA3-98009105, AA3-98009107, AA3-98009108, AA3-98009111, AA3-98009112, AA3-98009114, AA3-98009115, AA3-98009119, AA3-98009121, AA3-98009122, AA3-9C011236, AA3-9C011237, AA3-9C011238, AA3-9C011239, AA3-9C011243, AA3-9C011245, AA3-9C011246, AA3-9C011247, AA3-9C011248, AA3-9C011250, AA3-9C011251, AA3-9C011252, AA3-9C011253, AA3-9C011254, AA3-9C011255, AA3-9C011256, AA3-9C011257, AA3-9C011258, AA3-9C011902, AA3-03014704, AA3-03014706, AA3-03014711, AA3-04017479, AA3-04017486, AA3-04017490, AA3-04017492, AA3-04017495, AA3-04017498, AA3-04017775, AA3-04017776, AA3-04017779, AA3-04017780, AA3-04017781, AA3-04017782, AA3-04017783, AA3-04017786, AA3-04017788, AA3-04017789, AA3-04017792, AA3-04017918, AA3-04017919, AA3-04017920, AA3-04017921, AA3-04017922, AA3-04017923, AA3-04017924, AA3-04017925, AA3-04017926, AA3-04017927, AA3-04017928, AA3-04017929, AA3-04017931, AA3-04017932, AA3-06024004, AA3-07024280, AA3-07024255, AA3-07024410, AA3-07024424, AA3-92004796, AA3-92004797, AA3-94005814, AA3-94005816, AA3-94005817, AA3-94005818, AA3-94005819, AA3-94005820, AA3-94005821, AA3-94005822, AA3-94005823, AA3-94006411, AA3-98009118, AA3-05021348, AA3-05021352, AA3-06024002, AA3-06024012, AA3-06024029, AA3-06024031, AA3-06024035, AA3-06024049, AA3-06024050, AA3-06024055, AA3-05021359, AA3-06023471, AA3-06023760, AA3-07024294, AA3-03014713, AA3-03014851, AA3-03014870, AA3-03014871, AA3-03014872, AA3-04017480, AA3-04017481, AA3-04017482, AA3-04017483, AA3-04017484, AA3-04017485, AA3-04017487, AA3-04017488, AA3-04017489, AA3-04017493, AA3-04017494, AA3-04017496, AA3-04017497, AA3-04017773, AA3-04017774, AA3-04017777, AA3-04017778, AA3-04017784, AA3-04017787, AA3-04017791, AA3-04017930, AA3-07024283, AA3-07024286, AA3-07024288, AA3-07024291, AA3-07024296, AA3-07024297, AA3-07024298, AA3-07024299, AA3-07024300, AA3-07024304, AA3-07024305, AA3-07024308, AA3-07024309, AA3-07024310, AA3-07024311, AA3-07024312, AA3-04017785, AA3-05021345, AA3-05021354, AA3-06024067, AA3-94006413, AA3-98008780, AA3-06024038, AA3-06024042, AA3-04017794, AA3-05021451, AA3-05021459, AA3-06023746, AA3-06023754, AA3-06024043, AA3-06024046, AA3-06024063, AA3-06024077, AA3-07024251, AA3-94006403. 4. Used N1 Nellcor, ST: Part Number: Q6660E-PA00011; Serial Numbers: AA3-98009113. 5. N1 Nellcor, ST, Glasgow: Part Number: 6660E-PA00012; Serial Numbers: AA3-07024253, AA3-07024274, AA3-07024279, AA3-07024406, AA3-92004803, AA3-92004805, AA3-06024066, AA3-02013517, AA3-02013525, AA3-02013526, AA3-02013531, AA3-02013536, AA3-02013594, AA3-02013607, AA3-02013612, AA3-02013615, AA3-02013616, AA3-02013618, AA3-02013622, AA3-02013627, AA3-02013629, AA3-02013632, AA3-02013633, AA3-02013634, AA3-02013635, AA3-02013636, AA3-02013639, AA3-02013640, AA3-02013643, AA3-02013647, AA3-02013648, AA3-02013649, AA3-02013650, AA3-02013652, AA3-02013678, AA3-02013679, AA3-02013680, AA3-02013681, AA3-02013682, AA3-03014874, AA3-03014908, AA3-07024401, AA3-04017799, AA3-92004802, AA3-94005825, AA3-94005826, AA3-94005827, AA3-94005828, AA3-94005829, AA3-94006427, AA3-94006430, AA3-98009389, AA3-94006605, AA3-07024258, AA3-07024262, AA3-07024411, AA3-07024414, AA3-07024417, AA3-07024418, AA3-05020252, AA3-99009610, AA3-99009611, AA3-99009612, AA3-99009613, AA3-99009614, AA3-99009615, AA3-99009616, AA3-99009617, AA3-99009618, AA3-99009619, AA3-99009620, AA3-99009621, AA3-99009622, AA3-99009623, AA3-99009625, AA3-99009626, AA3-99009627, AA3-99009628, AA3-99009629, AA3-99009630, AA3-99009631, AA3-99009632, AA3-99009633, AA3-99009634, AA3-99009635, AA3-99009637, AA3-99009638, AA3-99009684, AA3-99009685, AA3-99009690, AA3-99009704, AA3-99009707, AA3-99009711, AA3-99009714, AA3-99009717, AA3-99009721, AA3-99009722, AA3-99009724, AA3-99009727, AA3-99009730, AA3-99009731, AA3-99009735, AA3-99009736, AA3-99009737, AA3-99009739, AA3-99009743, AA3-99009748, AA3-99009750, AA3-99009756, AA3-99009757, AA3-99009768, AA3-99009772, AA3-99009774, AA3-99009775, AA3-99009777, AA3-99009778, AA3-99009780, AA3-99009782, AA3-03014909, AA3-03014916, AA3-03014917, AA3-03014920, AA3-03014675, AA3-03014676, AA3-03014681, AA3-03014697, AA3-04017499, AA3-04017500, AA3-04017501, AA3-04017502, AA3-04017503, AA3-04017504, AA3-04017505, AA3-04017506, AA3-04017508, AA3-05020230, AA3-05020231, AA3-05020235, AA3-05020240, AA3-05020242, AA3-05020246, AA3-05020247, AA3-05020248, AA3-05020253, AA3-05020256, AA3-05020257, AA3-98008977, AA3-99009706, AA3-99009779, AA3-02013674, AA3-03013797, AA3-03014660, AA3-03014662, AA3-03014663, AA3-03014664, AA3-03014667, AA3-03014668, AA3-03014670, AA3-03014671, AA3-03014672, AA3-03014673, AA3-03014674, AA3-03014677, AA3-03014678, AA3-03014679, AA3-03014680, AA3-03014682, AA3-03014683, AA3-03014684, AA3-03014686, AA3-03014688, AA3-03014690, AA3-03014691, AA3-03014695, AA3-03014698, AA3-04017507, AA3-06023454, AA3-06023455, AA3-06023456, AA3-06023458, AA3-06023461, AA3-06023463, AA3-06023465, AA3-06023467, AA3-06023468, AA3-06023473, AA3-06023474, AA3-99009686, AA3-99009687, AA3-99009688, AA3-99009689, AA3-99009691, AA3-99009692, AA3-99009695, AA3-99009696, AA3-99009697, AA3-99009698, AA3-99009699, AA3-99009702, AA3-99009712, AA3-99009713, AA3-99009716, AA3-99009726, AA3-99009728, AA3-99009729, AA3-99009732, AA3-9C011261, AA3-9C011262, AA3-9C011263, AA3-9C011264, AA3-9C011266, AA3-9C011267, AA3-9C011268, AA3-9C011270, AA3-9C011271, AA3-9C011274, AA3-9C011275, AA3-9C011276, AA3-9C011277, AA3-9C011278, AA3-9C011279, AA3-9C011280, AA3-9C011921, AA3-9C011922, AA3-9C011923, AA3-9C011925, AA3-9C011930, AA3-9C011931, AA3-9C011932, AA3-9C011933, AA3-9C011934, AA3-9C011935, AA3-9C011936, AA3-9C011937, AA3-9C011938, AA3-9C011939, AA3-9C011940, AA3-9C012025, AA3-9C012026, AA3-9C012027, AA3-9C012028, AA3-9C012029, AA3-9C012030, AA3-9C012031, AA3-9C012032, AA3-9C012033, AA3-9C012034, AA3-9C012035, AA3-9C012036, AA3-9C012037, AA3-9C012038, AA3-9C012039, AA3-9C012040, AA3-9C012041, AA3-9C012042, AA3-9C012043, AA3-9C012044, AA3-06024006, AA3-06024052, AA3-07024277, AA3-07024404, AA3-8C003930, AA3-91004195, AA3-91004196, AA3-06024062, AA3-07024403, AA3-03014666, AA3-03014669, AA3-03014694, AA3-04017796, AA3-04017801, AA3-04017808, AA3-04017810, AA3-04017811, AA3-04017812, AA3-04017813, AA3-04017816, AA3-04017817, AA3-05020229, AA3-05020232, AA3-05020236, AA3-05020245, AA3-04017795, AA3-06023453, AA3-06023464, AA3-06023488, AA3-04017798, AA3-04017800, AA3-04017804, AA3-04017806, AA3-06023457, AA3-06023462, AA3-06023466, AA3-06023469, AA3-06023470, AA3-06023472, AA3-06023475, AA3-06023477, AA3-06023478, AA3-06023480, AA3-06023482, AA3-06023483, AA3-06023484, AA3-06023485, AA3-06023486, AA3-06023487, AA3-06023490, AA3-06023491, AA3-06023493, AA3-06023494, AA3-06023496, AA3-06023497, AA3-06023498, AA3-06023499, AA3-06023500, AA3-06023502, AA3-06023995, AA3-06023996, AA3-06023997, AA3-06023998, AA3-06024005, AA3-06024034, AA3-06024037, AA3-06024039, AA3-06024040, AA3-06024041, AA3-06024044, AA3-06024051, AA3-06024054, AA3-06024057, AA3-06024058, AA3-06024059, AA3-06024060, AA3-06024061, AA3-06024065, AA3-06024068, AA3-06024071, AA3-06024073, AA3-06024070, AA3-07024254, AA3-07024256, AA3-07024270, AA3-07024271, AA3-07024272, AA3-07024273, AA3-07024278, AA3-07024282, AA3-07024394, AA3-07024396, AA3-07024398, AA3-07024408, AA3-07024420, AA3-07024423, AA3-02013477, AA3-02013479, AA3-02013480, AA3-02013482, AA3-02013483, AA3-02013484, AA3-02013485, AA3-02013486, AA3-02013489, AA3-02013493, AA3-02013495, AA3-02013496, AA3-02013497, AA3-02013501, AA3-02013503, AA3-07024402, AA3-07024412, AA3-07024413, AA3-94005824, AA3-94006417, AA3-94006418, AA3-94006419, AA3-94006420, AA3-94006421, AA3-94006422, AA3-94006423, AA3-94006424, AA3-94006425, AA3-94006426, AA3-94006428, AA3-94006429, AA3-94006431, AA3-94006602, AA3-94006604, AA3-94006606, AA3-98008751, AA3-98008752, AA3-98008753, AA3-98008754, AA3-98008755, AA3-98008756, AA3-98008757, AA3-98008758, AA3-98008759, AA3-98008760, AA3-98009390, AA3-98009391, AA3-98009392, AA3-98009394, AA3-98009395, AA3-98009396, AA3-02013604, AA3-03013803, AA3-03014665, AA3-03014685, AA3-03014687, AA3-03014689, AA3-03014692, AA3-03014693, AA3-03014696, AA3-03014699, AA3-03014873, AA3-03014875, AA3-03014877, AA3-03014878, AA3-03014879, AA3-03014882, AA3-03014911, AA3-03014913, AA3-03014915, AA3-03014919, AA3-03014921, AA3-03014922, AA3-03014925, AA3-03014929, AA3-07024281, AA3-05020233, AA3-07024397, AA3-98008942, AA3-98008943, AA3-98008969, AA3-98008972, AA3-98009393, AA3-02013510, AA3-02013514, AA3-02013518, AA3-02013519, AA3-02013522, AA3-02013523, AA3-02013528, AA3-02013529, AA3-02013534, AA3-02013605, AA3-02013630, AA3-02013631, AA3-02013637, AA3-02013641, AA3-03013806, AA3-02013478, AA3-02013487, AA3-02013488, AA3-02013492, AA3-02013494, AA3-02013499, AA3-02013... |
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 - Nationwide distribution and the country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 1, 2025
- Recall initiation date
- Aug 15, 2025
- Center classification date
- Sep 25, 2025
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.