Prestilix
Recall
- Recall Number
- Z-0914-2017
- Event Number
- 75851
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 21, 2016
- Terminated
- September 26, 2017
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
Prestilix
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.
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.
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 Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam
Total for all products 1,598 (USA 824, OUS 774)