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FDA (Device enforcement)Recalled 2018-03-29closedclass ii

GE Medical Systems, SCS: Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

Is my product affected?

Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

  • UPC 083172440628
  • UPC 082416140028

Check against the official notice below — it lists the full affected range.

What happened

GE Medical Systems is recalling 102 Discovery IGS and Innova IGS interventional fluoroscopic X-ray systems distributed across multiple U.S. states and international locations. These systems may experience X-ray abort errors that could cause a loss of imaging mode either before or during fluoroscopic use.

The recall affects specific serial numbers of Model Number 5730890 systems. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. 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. Quantity: 102 devices total Lot/code info: 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).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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