Recall archive / FDA device enforcement
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4... — FDA record Z-1486-2025
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 Feb 19, 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
- GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
- Reason
- There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
- Classification
- Class II
- Recalling firm
- GE Healthcare
- Quantity
- 633 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1486-2025
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 | Model/Catalog/Code # 2033901-001, Installed Product ID 14335625-Centricity CA1000-19675863, UDI UDI Not Required, System ID HCIT4082079CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11558-1-Centricity CA1000-00099550, UDI UDI Not Required, System ID 520855CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103987-1-Centricity CA1000-00102841, UDI UDI Not Required, System ID 928537CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9990-1-Centricity CA1000-00101135, UDI UDI not required, System ID 661327CWS01; Model/Catalog/Code # 2038437-001, Installed Product ID 10318-1-Centricity CA1000-00105877, UDI UDI not required, System ID 818397CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10994-1-Centricity CA1000-00102387, UDI UDI Not required, System ID 909464CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102131-1-Centricity CA1000-00105886, UDI UDI not required, System ID 818409CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4161-1-Centricity CA1000-00105894, UDI UDI Not Required, System ID 818502CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103743-1-Centricity CA1000-00099665, UDI UDI Not Required, System ID 559582CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4408-2-Centricity CA1000-00101725, UDI UDI not required, System ID 714843CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 4532-4-Centricity CA1000-00107356, UDI UDI Not Required, System ID 310673CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4009-2-Centricity CA1000-00100791, UDI UDI not required, System ID 619260CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1354-8-Centricity CA1000-00102389, UDI UDI not required, System ID 909558CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9927-2-Centricity CA1000-00099762, UDI UDI not required, System ID 562491CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11299-9-Centricity CA1000-00109567, UDI UDI Not Required, System ID SVMCA6; Model/Catalog/Code # 2038437-001, Installed Product ID 4446-2-Centricity CA1000-00107805, UDI (01)00840682125260(10)20P14H2038437016, System ID 323726CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103447-1-Centricity CA1000-22271916, UDI (01)00840682125260(10)20P14J2038437016, System ID CALIFORNIA22271916; Model/Catalog/Code # 2038437-001, Installed Product ID 100256-3-Centricity CA1000-00101156, UDI (01)00840682125260(10)20P14J2038437016, System ID 661948CA1RSW; Model/Catalog/Code # 2038437-001, Installed Product ID 11169-1-Centricity CA1000-00102586, UDI UDI not required, System ID 916225CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1223-17-Centricity CA1000-00106365, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 858554CA1SW14; Model/Catalog/Code # 2038437-001, Installed Product ID 1845-2-Centricity CA1000-00100829, UDI UDI not required, System ID 619691CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 2195-12-Centricity CA1000-16385905, UDI UDI Not Required, System ID UCLAMC16385905; Model/Catalog/Code # 2038437-001, Installed Product ID 9985-1-Centricity CA1000-00106974, UDI UDI not required, System ID 303695CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103533-5-Centricity CA1000-02299486, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID BOULDERCO02299486; Model/Catalog/Code # 2038437-001, Installed Product ID 10617-1-Centricity CA1000-00107034, UDI UDI not required, System ID 303839CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100385-1-Centricity CA1000-00106873, UDI UDI not required, System ID 303320CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10482-1-Centricity CA1000-00103250, UDI UDI not required, System ID 970764CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10841-1-Centricity CA1000-00106998, UDI UDI not required, System ID 303788CVIT5; Model/Catalog/Code # 2038437-001, Installed Product ID 9900-1-Centricity CA1000-00106902, UDI UDI not required, System ID 303451CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 2386-2-Centricity CA1000-00116051, UDI UDI not required, System ID 203276CA1000RV1; Model/Catalog/Code # 2038437-001, Installed Product ID 101581-1-Centricity CA1000-00095981, UDI UDI not required, System ID 202745CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4698-3-Centricity CA1000-00108747, UDI UDI not required, System ID MCTHCA10001; Model/Catalog/Code # 2038437-001, Installed Product ID 101194-2-Centricity CA1000-00103078, UDI UDI not required, System ID 941792HCA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10298-1-Centricity CA1000-00105482, UDI UDI not required, System ID 813681CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10298-1-Centricity CA1000-00105491, UDI UDI not required, System ID 813681CA1SW19; Model/Catalog/Code # 2038437-001, Installed Product ID 11209-1-Centricity CA1000-00095905, UDI UDI not required, System ID 0004053422A; Model/Catalog/Code # 2038437-001, Installed Product ID 10218-4-Centricity CA1000-00108483, UDI UDI not required, System ID FWBCA1005; Model/Catalog/Code # 2038437-001, Installed Product ID 10218-2-Centricity CA1000-00095912, UDI UDI not required, System ID FWBCA14; Model/Catalog/Code # 2038437-001, Installed Product ID 103638-1-Centricity CA1000-00107955, UDI UDI not required, System ID 352331CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10849-3-Centricity CA1000-00107230, UDI UDI Not Required, System ID 305364CA2100; Model/Catalog/Code # 2038437-001, Installed Product ID 103203-1-Centricity CA1000-22144957, UDI (01)00840682125260(10)20P14J2038437016, System ID BIHT22144957; Model/Catalog/Code # 2038437-001, Installed Product ID 10458-5-Centricity CA1000-00102189, UDI UDI not required, System ID 904399HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11208-2-Centricity CA1000-00103172, UDI UDI not required, System ID 954974CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 101427-1-Centricity CA1000-00104669, UDI UDI not required, System ID 727848HCA1SW7; Model/Catalog/Code # 2038437-001, Installed Product ID 10264-1-Centricity CA1000-00095914, UDI UDI not required, System ID 850769HCA1SW11; Model/Catalog/Code # 2038437-001, Installed Product ID 101180-1-Centricity CA1000-00104672, UDI UDI not required, System ID 727863CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103577-2-Centricity CA1000-00104941, UDI UDI not required, System ID 772581CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 104179-1-Centricity CA1000-00104625, UDI UDI Not required, System ID 727521CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103788-1-Centricity CA1000-00104637, UDI UDI not required, System ID 727521OPCA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11639-1-Centricity CA1000-00104600, UDI UDI not required, System ID 727384CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10475-1-Centricity CA1000-00097981, UDI UDI not required, System ID 407321SWCA1; Model/Catalog/Code # 2038437-001, Installed Product ID 11041-1-Centricity CA1000-00103047, UDI UDI Not Required, System ID 941342CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11743-1-Centricity CA1000-00095913, UDI (01)00840682125260(10)20P14H2038437016, System ID 0004275549A; Model/Catalog/Code # 2038437-001, Installed Product ID 11743-1-Centricity CA1000-01973685, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 850325HCA1SW5; Model/Catalog/Code # 2038437-001, Installed Product ID 13367-1-Centricity CA1000-02041150, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID HCAE02041150; Model/Catalog/Code # 2038437-001, Installed Product ID 100620-13-Centricity CA1000-00163680, UDI UDI not required, System ID 813885HCA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1657-7-Centricity CA1000-00105550, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID 813971CA10003; Model/Catalog/Code # 2038437-001, Installed Product ID 10292-2-Centricity CA1000-00104678, UDI UDI Not Required, System ID 727942CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100115-1-Centricity CA1000-00101433, UDI UDI Not Required, System ID 706651HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3901-2-Centricity CA1000-00101421, UDI UDI not required, System ID 706596CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10147-2-Centricity CA1000-22155331, UDI (01)00840682125260(10)20P14J2038437016, System ID CRH522155331; Model/Catalog/Code # 2038437-001, Installed Product ID 9847-2-Centricity CA1000-00108204, UDI UDI not required, System ID 404501CA1SW1A; Model/Catalog/Code # 2038437-001, Installed Product ID 10209-1-Centricity CA1000-00098680, UDI UDI Not Required, System ID 478274CA1SW100; Model/Catalog/Code # 2038437-001, Installed Product ID 11047-6-Centricity CA1000-00101185, UDI UDI not required, System ID 678957CA1; Model/Catalog/Code # 2038437-001, Installed Product ID 11047-6-Centricity CA1000-00101186, UDI UDI not required, System ID 678957CA2; Model/Catalog/Code # 2038437-001, Installed Product ID 3929-2-Centricity CA1000-00105388, UDI UDI not required, System ID 808485CA1SW2; Model/Catalog/Code # 2038437-001, Installed Product ID 1458-6-Centricity CA1000-00107439, UDI UDI Not Required, System ID 312RUSH1CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 1566-4-Centricity CA1000-00102050, UDI UDI not required, System ID 877453CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1566-4-Centricity CA1000-00102051, UDI UDI not required, System ID 877453CA1SW2; Model/Catalog/Code # 2038437-001, Installed Product ID 101349-2-Centricity CA1000-00109702, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID UICCA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 101349-2-Centricity CA1000-22176245, UDI (01)00840682125260(10)20P14J2038437016, System ID UIMC22176245; Model/Catalog/Code # 2038437-001, Installed Product ID 101454-1-Centricity CA1000-00101519, UDI UDI Not Required, System ID 708202CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10691-2-Centricity CA1000-00096590, UDI UDI Not required, System ID 217258CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11367-1-Centricity CA1000-00101569, UDI UDI not required, System ID 708681CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10251-3-Centricity CA1000-00100783, UDI UDI not required, System ID 618241CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100086-1-Centricity CA1000-00107335, UDI UDI not required, System ID 309CA1000SW4; Model/Catalog/Code # 2038437-001, Installed Product ID 1250-1-Centricity CA1000-00101545, UDI UDI Not Required, System ID 708361CA1000SW; Model/Catalog/Code # 2038437-001, Installed Product ID 1237-1-Centricity CA1000-00103189, UDI UDI Not Required, System ID 956544CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3832-1-Centricity CA1000-00105463, UDI UDI not required, System ID 812858CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 8637-1-Centricity CA1000-00107663, UDI UDI not required, System ID 317621CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3864-3-Centricity CA1000-00105445, UDI (01)00840682125260(10)20P14J2038437016, System ID 812482CA1SW; Model/Catalog/Code # 2038437-001, Installed Product ID 102796-1-Centricity CA1000-00104871, UDI UDI not required, System ID 765671CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10943-1-Centricity CA1000-00107645, UDI (01)00840682125260(10)20P14F2038437016, System ID 316962HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103613-1-Centricity CA1000-00107629, UDI UDI not required, System ID 316858HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103897-1-Centricity CA1000-00097067, UDI (01)00840682125260(10)2... |
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
- Apr 9, 2025
- Recall initiation date
- Feb 19, 2025
- Center classification date
- Mar 28, 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.