Canon Aquilion Premium recall
Canon Aquilion Premium, Model TSX-301B
Why was Canon Aquilion Premium recalled?
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Canon Aquilion Whole-Body X-Ray CT Scanner, 160-detector row CT, Model TSX-301B - Serial numbers 7CA18Y2002 and 7CA1892001.
- Product
- Canon Aquilion Premium, Model TSX-301B
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 2 devices
- Distribution
- Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no foreign distribution.
- Recall date
- April 22, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)