Recall – CT Scanner does not proceed to next scan

Company: Canon Medical System, USA, INC.
Date of Enforcement Report: 10/27/2021
Class II

PRODUCT

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

Recall Number: Z-0142-2022

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.

RECALLING FIRM/MANUFACTURER

Canon Medical System, USA, INC. on 11/11/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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