| Class 2 Device Recall Discovery IGS 730 Interventional Fluoroscopic Xray Systems | |
Date Initiated by Firm | March 29, 2018 |
Date Posted | October 05, 2018 |
Recall Status1 |
Terminated 3 on June 15, 2021 |
Recall Number | Z-2386-2018 |
Recall Event ID |
80177 |
510(K)Number | K113403 K122457 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product | Discovery IGS 730 Interventional Fluoroscopic X-ray Systems |
Code Information |
Model Number 5730890, Serial Numbers (System ID): 00000D3-17-030 (904BHHCHY), 00000D3-17-032 (083172440628), 661327IGS730 (00000D3-18-001), GON4598369 (00000D3-18-004), 082416140028 (00000D3-17-025), M4234253 (00000D3-17-028), YV3601 (00000D3-18-005), 6073XR0058 (00000D3-17-031). |
Recalling Firm/ Manufacturer |
GE Medical Systems, SCS 283 rue de la Miniere Buc France
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Manufacturer 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. |
FDA Determined Cause 2 | Process control |
Action | 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. |
Quantity in Commerce | 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, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey, United Kingdom, Vietnam. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = OWB 510(K)s with Product Code = OWB
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