Recall Z-0914-2017

GE Healthcare, LLC · initiated November 21, 2016

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Prestilix

Codes / lots: Mfg. Lot or Serial # System ID Not Available 1301 Not Available 318783ARF Not Available 412488F1 Not Available AP3001XR10 Not Available 902567GI Not Available C4211004 00000048037YY6 PC7281XR02 Not Available PC0731XR01 Not Available A5816801 00000022153YY1 C5304806 00000023739YY6 PL1020RX01 Not Available RU1146RX01

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-0914-2017
Initiated
November 21, 2016
Terminated
September 26, 2017
Product code
LLZ – System, Image Processing, Radiological
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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0904-2017 Class IIInnova 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 IIADVANTX 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 IIADVANTX 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 IIADVANTX 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 IIADVANTX 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 IILegacyGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… 11/21/2016Terminated
Z-0910-2017 Class IIPrecision 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 IIPrestige 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 IIPrestige 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 IIPrestige VHGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… 11/21/2016Terminated
Z-0915-2017 Class IIRFXGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… 11/21/2016Terminated
Z-0916-2017 Class IISFXGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… 11/21/2016Terminated