Discovery IGS 730 Interventional Fluoroscopic X-ray Systems recallZ-2386-2018 · GE Medical Systems, SCS · initiated Mar 29, 2018
Class II Terminated All recalls posted in October 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Medical Systems, SCS or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2386-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 29, 2018
- Posted by the FDA
- Oct 5, 2018
- Recalling firm
- GE Medical Systems, SCS
- Quantity
- 102 devices total
- Product code
- OWB
- FDA submissions
- K113403, K122457
- 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.
Product description
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
Code information (models, lots, serial numbers)
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).
Other devices under the same FDA submission
1 device cleared under K113403, K122457 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INNOVA IGS 5 001Ge Medical Systems · System, x-ray, fluoroscopic, image-intensified1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 80177).
- Z-2387-2018 · TerminatedInnova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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