FDAClass IIJuly 18, 2018

Discovery IGS 730 Interventional Fluoroscopic X-ray recall

Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

Why was Discovery IGS 730 Interventional Fluoroscopic X-ray 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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).

Product
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
Recalling firm
GE Medical Systems, SCS
Quantity
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.
Recall date
July 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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