Product Wiki · Recalls · Health Canada — Medical Devices

Lightspeed 16 CT Scanner and Discovery PET/CT 600 Systems (2016-02-05) — recall 54901

Health Canada — Medical Devices · Canada · 2016-02-12 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54901
Date of alert
2016-02-12
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: GEHC has updated the service manuals used to maintain these scanners to fix an incorrect torque value, which is the source of the field action. FMI 25463 identified a torque issue with 5 volt supplies in CT and PET LightSpeed systems and corrected the issue by field action, as well as a technical manual update. This recall is to send a second customer letter to anyone who may still possess and use an obsoleted service manual.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/lightspeed-16-ct-scanner-and-d

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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