Reported Nov 13, 2024 · Ongoing
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines…
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?
- Cartesion Prime, Digital PET-CT
- ModelPCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems
- Lot codes and dates
- UDI-DI04987670103810
- Software
V10.8 SP0013V10.15 SP0006
- Serial Numbers
3DA19820013DA20720023DA20720033DA20X20043DA20Y20053DA21120063DA21320073DA21620083DA21920093DA22420103DA22520113DA22620123DA22720133DA22720143DA22820153DA22920163DA22Y20173DA22Z20183DA23220193DA23220203DA23320213DA23320223DA23420233DA23520243DA23520253DB23620263DB2422029
- Amount recalled
- 27
Where it was sold
Why it was recalled
When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Canon Medical System, USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.