iMRX MRI and Angiography System recall
iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The…
Why was iMRX MRI and Angiography System recalled?
There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible
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?
Serial Number: 146792, 153374, 153642, 153793, 153896, 154588.
- Product
- iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The…
- Recalling firm
- Deerfield Imaging, Inc.
- Quantity
- 6
- Distribution
- CT, MA, VA. International distribution: Australia, Canada, and Qatar.
- Recall date
- January 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)