The Recall Desk
SevereFDA (Devices)·Z-0088-2017·Announced 2016-10-26

SenTec Digital Monitoring System Recalled for Fire and Shock Risk

SenTec AG is recalling 75 SDMS units because a loose screw may cause short circuits, leading to fire or electrical shock.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire and electrical shock, which constitutes a significant injury risk under the rubric for Severe (4) recalls.

Plain-English summary

SenTec AG is recalling 75 units of the SDMS (SenTec Digital Monitoring System) due to a defect in the Docking Station Module. The recall affects serial numbers 306497 through 306571. The units were distributed worldwide, including in the United States (Louisiana, Michigan, Missouri, Ohio, and Tennessee), the United Kingdom, the Netherlands, and Australia.

The recall was initiated because a fastening screw in the monitor component may become loose under certain circumstances. This defect can create uncontrolled electrical connections, including short circuits, which pose a risk of smolder, fire, and electrical shock to patients and operators.

Consumers and healthcare facilities should stop using the affected devices immediately. SenTec AG is the recalling firm responsible for managing the recall.

The recalled product

Product
SDMS (SenTec Digital Monitoring System)
Manufacturer
SenTec AG
Category
Medical Device — Monitoring System
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • SN 306497 to SN 306571.

Distribution

Distributed in 5 states:

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