Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
FDA Recall Z-0142-2022 · Posted None
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Recalling FirmCanon Medical System, USA, INC.
Recall StatusTerminated
Product CodeKPS
Date Initiated2020-11-11
Date Terminated2023-06-30
Product Quantity3 units
Reason for Recall
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.
Firm Action
On November 11, 2020, Canon Medical Systems visited affected consignees and updated affected software. After completion of the software update, the consignee was provided a "Recall field Modification Instruction" document concerning the correction.
Root Cause
Software design
Distribution Pattern
US Nationwide distribution in the states of NV, AR MN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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