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Recall

RegulatorsFDAUSA

Covidien MonaTherm General Purpose Temperature Probe Recall (Class 2)

Regulatory action
Class 2 Device Recall
Philips Azurion 5M12 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Relevant for
Regulatory Intelligence LeadSignal Management Lead
Action needed

Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.

Process impact
Signal ManagementLabeling
SOP impact

2 SOPs may need review

Urgency: HighConfidence: high
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RegulatorsFda

FDA ties TRUE METRIX Safety Communication to Class I recall update

Relevant for
Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadMedical Device Vigilance Lead+3 more
Action needed

Fda update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

Process impact
Signal ValidationLocal Affiliate ComplianceDevice Vigilance
SOP impact

7 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →

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Tag: Recall | PV Bulletin