Recall – CT Scan system error prevents normal shut down procedure

Company: Canon Medical System, USA, INC.
Date of Enforcement Report: 4/22/2020
Class II

PRODUCT

Canon Aquilion Lightning, Model TSX-036A

Recall Number: Z-1719-2020

REASON

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

RECALLING FIRM/MANUFACTURER

Canon Medical System, USA, INC. on 3/25/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

6 devices

DISTRIBUTION

US 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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