GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of h
FDA device recall Z-1248-2015 · posted 2015-03-06 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
- Action taken
- Consignees were sent on 1/30/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#17108 dated January 30, 2015. The letter was addressed 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 800-437-1171. Outside the US contact your local GE Healthcare Service Representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 192 (131 US, 61 OUS).
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI,and WV
- Date initiated
- 2015-01-30
- Date posted
- 2015-03-06
- Date terminated
- 2015-09-15
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILHOUETTE FC (K993090) | Ge Medical Systems, Inc. | 1999-10-01 |