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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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
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