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.

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

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