PV Bulletin

Covidien MonaTherm General Purpose Temperature Probe Recall (Class 2)

Covidien (Medtronic) recalls specific lots of MonaTherm probes due to potential incorrect temperature readings or quality defects.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

PV Impact Brief

Urgency: HighConfidence: high

What changed

FDA classified the Covidien MonaTherm probe recall as Class 2 and instructed users to quarantine and return unused products.

Why it matters

Incorrect temperature readings could lead to misdiagnosis or inappropriate patient management, posing serious safety risks.

Action needed

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

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

single event

Regulatory action details

Action type
Class 2 Device Recall
Publication date
2026-06-04
Safety issue
The system may sporadically display a 0 x-ray dose administered to the patient during fluoroscopy and/or single-frame acquisitions, even though an actual x-ray dose is being applied.

Affected products

  • ARTIS pheno interventional fluoroscopic x-ray system
    Siemens Medical Solutions USA, Inc

PV internal implications

Distribution of Customer Advisory Notice (CAN) to all affected customers.

View regulator source

Evidence and confidence

Confidence: highSource updated: May 29, 2026

Full briefing

Practical implication

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

The FDA announced a Class 2 recall by Covidien (Medtronic) for MonaTherm General Purpose Temperature Probe, lot Z-2273-2026. Users must quarantine and return unused products.

What changed: FDA classified the Covidien MonaTherm probe recall as Class 2 and instructed users to quarantine and return unused products.

Why it matters: Incorrect temperature readings could lead to misdiagnosis or inappropriate patient management, posing serious safety risks.

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

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals#Recall#FDA#safety_signal#firecrawl-agent#regulatory-extraction

Related updates for your role

publicFood and Drug Administration (FDA) · United States · Updated Jun 29, 2026

eMDR System Enhancements - Production Deployment

Urgency: High

Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Notice
Read impact briefarrow_forward
publicTherapeutics Goods Administration · Australia · Updated Jul 20, 2026

Updates on ISO 14155 and N=1 Therapeutics Discussed by TGA

Urgency: High

Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.

Inspection ReadinessICSRRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Notice
Read impact briefarrow_forward
publicEuropean Medicines Agency (EMA) · European Union · Updated Jul 20, 2026

CHMP Draft Agenda for Public Consultation on Thalassaemia and Sickle Cell Disease Guidelines

Urgency: High

Sponsors and MAHs must review and align safety data collection and reporting protocols with the newly adopted guidelines while preparing for implementation of PRAC recommendations stemming from this meeting.

Signal ManagementICSRRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Agenda
Read impact briefarrow_forward
publicSwissmedic · Switzerland · Updated Jul 17, 2026

Checklist for the Inspection of Medical Device Vigilance in Hospitals

Urgency: High

Healthcare facilities must utilize the new checklist during inspections to conduct gap analyses and ensure compliance with reporting requirements associated with their vigilance systems.

Inspection ReadinessRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Checklist
Read impact briefarrow_forward