Product Wiki · Recalls · Health Canada — Medical Devices

DigitalDiagnost — recall 48393

Health Canada — Medical Devices · Canada · 2012-09-03 · Type III

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →

Agency: Health Canada — Medical Devices
Recall identifier: 48393
Date of alert: 2012-09-03
Country / jurisdiction: Canada
Risk level: Type III
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: Philips has discovered an issue in the M-Cabinet of the Digitaldiagnost. The creepage distance between the two primary phases in the Geo Transformer is 4.5mm. According to IEC 60601-1 (2nd edition, clause 57.10), the international standard governing electrical specifications for electronic products, the creepage distance for a 500V AC (As found in the M-Cabinet) has to be 5.5mm.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/digitaldiagnost

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.

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.

DigitalDiagnost — recall 48393

Related