GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic i
FDA device recall Z-1966-2015 · posted 2015-07-02 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#10902 dated June 12, 2015 to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 4,053 (3,804 US; 249 OUS)
- Distribution
- Worldwide Distribution - US Nationwide including PR, GU and DC and the countries of: Afghanistan, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Czech Republ
- Date initiated
- 2015-06-12
- Date posted
- 2015-07-02
- Date terminated
- 2015-12-21
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRECISION 500D R&F X-RAY SYSTEM (K081091) | GE Healthcare | 2008-06-11 |
| LEGACY/LEGACY-D TABLE (K973039) | GE Medical Systems | 1997-10-16 |