Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
FDA device recall Z-2386-2018 · posted 2018-10-05 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, SCS
- Reason for recall
- The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
- Action taken
- GE Healthcare notified customers on approximately 03/29/2018, via an URGENT MEDICAL DEVICE CORRECTION letter. Safety instructions included that before each use, to ensure the IGS system is fully functional as indicated in the GE product labeling and follow each facility's established procedures before and during each use to manage the patient if a repeated X-ray abort error occurs during the procedure or in the case a complete loss of fluoroscopic viewing capability may occur. If the problem persists, customers are instructed to contact their local GE Healthcare Service Representative. Additionally, customers are instructed that GE Healthcare will correct all affected products at no cost and a GE Healthcare representative will contact each customer to arrange for the correction. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or the local Service Representative.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 102 devices total
- Distribution
- US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Jap
- Date initiated
- 2018-03-29
- Date posted
- 2018-10-05
- Date terminated
- 2021-06-15
- Location
- Buc, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS (K122457) | GE Healthcare | 2013-01-02 |
| GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM (K113403) | GE Medical Systems SCS | 2012-02-14 |