Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SDMS (SenTec Digital Monitoring System) Recalled by SenTec AG Due to Sentec AG found that with one batch of...

Date: September 15, 2016
Company: SenTec AG
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SenTec AG directly.

Affected Products

SDMS (SenTec Digital Monitoring System)

Quantity: 75 (54 US; 21 =OUS)

Why Was This Recalled?

Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).

Where Was This Sold?

This product was distributed to 5 states: LA, MI, MO, OH, TN

Affected (5 states)Not affected

About SenTec AG

SenTec AG has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report