Recall Z-0906-2017
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
ADVANTX LCLP+
Codes / lots: Mfg. Lot or Serial # System ID 00000047915YY4 415540ADVLCLP 00000063721YY5 909865LCLP Not Available 916734XR 00000063736YY3 MCTHKGMN 00000023830YY3 912633MCL1 00000023761YY0 912633MCL1 00000128484M03 312CCHGECATH 00000128484MO3 312CCHGECATH Not Available 507255CC101 Not Available LIJ015064 00000026160YY2 210428VCATH2 00000063805YY6 BPEP Not Available 414C4862 00000022150YY7 YX0738
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-0906-2017
- Initiated
- November 21, 2016
- Terminated
- September 26, 2017
- Product code
- IZI – System, X-Ray, Angiographic
- 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-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-0912-2017 Class II | Prestige SIGE 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 |