Recall Z-0912-2017
GE Healthcare, LLC · initiated November 21, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Prestige SI
Codes / lots: Mfg. Lot or Serial # System ID Not Available 310665PREST 00000047974YY1 1711 Not Available 708799SPHR 00000026137YY0 708216L11 Not Available 219886NLP Not Available 504380LP3 00000031369YY2 201754PRES Not Available 718250RM2 00000031404YY7 330385FL6 Not Available 803464PRES 00000026140YY4 AP5821XR04 Not Available 519837REM Not Available 905565REM 00000031306YY4 514468BPRESTIGE 00000052130YY2 514468BPRESTIGE 00000034288YY1 514495PRESTIGE Not Available M9864607 Not Available M4261103 00000048089YY7 A5218915 00000047968YY3 PER18303
Reason for recall
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
FDA-determined cause: Nonconforming Material/Component
Action taken
Consignees were sent on 11/21/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10913 dated November 21, 2016. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Details
- Recall number
- Z-0912-2017
- Initiated
- November 21, 2016
- Terminated
- September 26, 2017
- Product code
- JAA – System, X-Ray, Fluoroscopic, Image-Intensified
- Quantity
- Total for all products 1,598 (USA 824, OUS 774)
- Distribution
- US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland…
- Recalling firm
- GE Healthcare, LLC, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0904-2017 Class II | Innova 2000GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0905-2017 Class II | ADVANTX LCAGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0906-2017 Class II | ADVANTX LCLP+GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0907-2017 Class II | ADVANTX LCN+GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0908-2017 Class II | ADVANTX LCV+GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0909-2017 Class II | LegacyGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0910-2017 Class II | Precision 500DGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0911-2017 Class II | Prestige IIGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0913-2017 Class II | Prestige VHGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0914-2017 Class II | PrestilixGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0915-2017 Class II | RFXGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |
| Z-0916-2017 Class II | SFXGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | 11/21/2016Terminated |