Reported Dec 16, 2020 · Terminated
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display…
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 Prime SP, Multislice Helical CT Scanner
- TSX-303B/8L - Product Usageintended to acquire and display cross-sectional volumes of the whole body, including the head
- Lot codes and dates
- Serial Numbers
69 of 69 codes
8LA20520638LA19Z20348LA19X20048LA19Z20278LA19Z20298LA20520628LA20420558LA19Z20328OA20520598LA20420518LA20320448LA19X20021LB19221758LA20420508LA19X20078LA20120378LA19Y20218LA19Y20148LA20420568LA19Z20238LA20520678LA19Z20318LA19Y20198LA19Z20308OA19Y20138LA19Z20288LA19Y20128LA19Y20208LA20320428LA20520668LA19X20038LA19Y20228LA19X20088LA20420478LA19Z20248LA20320468LA19Z20338OA20420538LA20120368LA20420548LA19Z20258LA19Z20268LA20220418LA19X20108LA20320438OA19X20018OA20520618OA20420498LA19Y20168LA20220398LA19Y20158LA20120358LA20320458LA19Y20188LA19X20058LA19X20068LA19X20098LA19Y20118LA19Y20178LA2012038
- Serial Numbers
- Amount recalled
- 60 units
Where it was sold
- Nationwide
Why it was recalled
A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan 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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