GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated f
FDA device recall Z-0966-2015 · posted 2015-01-14 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
- Action taken
- Consignees were sent a 12/10/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 12223 dated December 10, 2014. 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 ( US call 800-437-1171, other countries contact your local GE Healthcare Service Representative).
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 24 ( 7 US, 17 OUS)
- Distribution
- Worldwide Distribution-Distributed in the states of CO, CT, MS, NJ, NY, OH, and WA, and the countries of BELGIUM, CANADA, CHINA, FRANCE, GERMANY, JAPAN, MEXICO, PERU, UNITED ARAB EMIRATES, and UNITED
- Date initiated
- 2014-12-10
- Date posted
- 2015-01-14
- Date terminated
- 2015-06-01
- 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 |
|---|---|---|
| DISCOVERY IGS 740 (K133278) | GE Medical Systems SCS | 2014-04-24 |
| GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM (K113403) | GE Medical Systems SCS | 2012-02-14 |