Reported Apr 22, 2020 · Ongoing
Canon Aquilion Premium, Model TSX-301B
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Canon Aquilion Premium, Model TSX-301B
- Lot codes and dates
- Canon Aquilion Whole-Body X-Ray CT Scanner, 160-detector row CT, Model TSX-301B - Serial numbers 7CA18Y2002 and 7CA1892001.
- Amount recalled
- 2 devices
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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