GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be
FDA device recall Z-0010-2015 · posted 2014-10-02 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.
- Action taken
- Consignees were sent on 9/5/2014 a GE Healthcare "Urgent Medical Device Letter" GE Ref:10893, dated September 5, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology & Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in USA call 800-437-1171, for other countries contact your local GE Healthcare Service Representative.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 204 (199 US, 5 OUS).
- Distribution
- Worldwide Distribution - US Nationwide - AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI a
- Date initiated
- 2014-09-05
- Date posted
- 2014-10-02
- Date terminated
- 2015-02-20
- 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 |