Changeflow GovPing Healthcare & Life Sciences ANSM Safety Alert: Radius VSM ECG Electrodes an...
Priority review Enforcement Removed Final

ANSM Safety Alert: Radius VSM ECG Electrodes and Blood Pressure Cuffs

Favicon for ansm.sante.fr ANSM Drug & Device Safety Alerts
Detected
Email

Summary

The French ANSM has issued a safety alert regarding a lot recall of Radius VSM ECG electrodes and blood pressure cuffs by Masimo Corporation. This action is registered under recall number R2607611 and is directed at pharmacies and healthcare facilities.

Published by ANSM on ansm.sante.fr . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert concerning a lot recall of Radius VSM ECG electrodes and blood pressure cuffs manufactured by Masimo Corporation. The recall, registered under number R2607611, affects specific batches of these medical devices. The alert is directed towards pharmacies, internal hospital pharmacies, and outpatient healthcare facilities.

Healthcare providers in possession of the affected lots should be aware of this recall and follow the instructions provided by Masimo Corporation, as detailed in the company's letter dated March 25, 2026. For any inquiries, users are advised to contact Masimo Corporation directly. This action highlights the importance of vigilance in medical device safety and adherence to recall procedures.

What to do next

  1. Identify and quarantine affected Radius VSM ECG electrodes and blood pressure cuffs.
  2. Follow instructions provided by Masimo Corporation for lot return or disposal.
  3. Consult Masimo Corporation directly for any questions regarding the recall.

Archived snapshot

Mar 25, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

A+ A-

Rappel n° R2607611 destiné aux pharmacies d'usage intérieur, officines et structures de soins de ville L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Masimo Corporation.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607611. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Masimo Corporation (25/03/2026)

Get daily alerts for ANSM Drug & Device Safety Alerts

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from ANSM.

What's AI-generated?

The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.

Last updated

Classification

Agency
ANSM
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2607611

Who this affects

Applies to
Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Product Recall Medical Device Safety
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Product Safety Healthcare

Get alerts for this source

We'll email you when ANSM Drug & Device Safety Alerts publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!