GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
FDA device recall Z-1706-2016 · posted 2016-05-23 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.
- Action taken
- Consignees were sent on 4/15/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12246 dated April 14, 2016. 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 or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 54
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGI
- Date initiated
- 2016-04-15
- Date posted
- 2016-05-23
- Date terminated
- 2016-11-22
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM (K113403) | GE Medical Systems SCS | 2012-02-14 |