System recall
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high…
Why was System recalled?
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
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: 5741000-23 and 5396469
- Product
- System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 30 devices total
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.
- Recall date
- October 28, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)