Reported Oct 27, 2021 · Terminated
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
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 PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
- Lot codes and dates
- Affected serial numbers
3DA19820013DA20720023DA2072003
- Affected serial numbers
- Amount recalled
- 3 units
Where it was sold
Why it was recalled
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
This product could cause temporary or reversible health problems — stop using it.
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