Product Wiki · Recalls · Health Canada — Medical Devices

Biograph mMR System (2020-04-30) — recall 61265

Health Canada — Medical Devices · Canada · 2020-05-15 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
61265
Date of alert
2020-05-15
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: This update provides a software update to N4 VE11P-SP04, which resolves the following issues and prevents them from recurring. The update is not providing new features or new functionality. These fixes do not affect patient safety. Patient ID and name were not anonymized in error cases. Improved service online help and online maintenance instruction (only for service) Added features and options already available with AP01: CP/EP mode & new option on the contrast - common parameter card
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/biograph-mmr-system-2020-04-30

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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.