VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 4529
FDA device recall Z-1083-2013 · posted 2013-04-10 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX and VMX Plus Mobile X-ray systems that may impact Operator or Patient safety.
- Action taken
- GE Healthcare sent and "Urgent Medical Device Correction" letter dated January 23, 2012. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details and Product Correction. For questions contact your local GE Healthcare Service Represenative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 1296
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: AR, CA, GA, IL, IN,IA,LA, MA, MN, MT, NY, OH, PA, TX, VA and the countries of BELGIUM, BURKINA FASO, BRAZIL, CHINA, CANADA, SWITZERLA
- Date initiated
- 2012-01-23
- Date posted
- 2013-04-10
- Date terminated
- 2014-02-04
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VMX MOBILE X-RAY SYSTEM (K910902) | GE Medical Systems | 1991-09-09 |