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Recall Observatory FDA recall evidence

Device product

Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

Z-0142-2022

November 11, 2020

Class II

Product summary

Firm
Canon Medical System, USA, INC.
Event
Event 88691
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0142-2022

Official wording

Reason: 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.

Code information: Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003

Distribution pattern: US Nationwide distribution in the states of NV, AR MN.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software problem