Use caution Medical device recall · FDA · Published December 10, 2020

SenTec SDM Patient Monitor: Requires Isolation Transformer for Safe Home Use

SenTec recalls SDM patient monitors sold without isolation transformers for home use. These devices may not meet safety standards, risking electrical hazards. Affected units have specific serial numbers listed.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1134-2021Medical device SenT:ec ›

Use caution until it’s fixed

Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

Take action

Contact the company

Recalling firmSenTec AGRingstrasse 39 · Therwil, Switzerland

✎ GovInfoNow plain-language explainer

SenTec recalls its SDM patient monitors because they require an isolation transformer for home use to meet safety standards. Without this, the monitors could pose electrical risks. Owners should check their serial numbers against the list provided. Read more at govinfonow.com/recall/63692-sentec-sdm-patient-monitor-requires-isolation-transformer-for-safe-home.

Source Summary by GovInfoNow · govinfonow.com/recall/63692-sentec-sdm-patient-monitor-requires-isolation-transformer-for-safe-home · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1134-2021

Cite this page

“SenTec SDM Patient Monitor: Requires Isolation Transformer for Safe Home Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63692-sentec-sdm-patient-monitor-requires-isolation-transformer-for-safe-home. Based on FDA recall #Z-1134-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1134-2021%22&limit=1).

SenTec AG voluntarily recalled its SenTec Digital Monitor, Model SDM, on Dec. 10, 2020, according to the FDA. The agency said the device requires an Isolation Transformer in home care settings to comply with safety standards.

How to tell if you have it

Brand: SenTec
Model: SDM
Serial Numbers: 303170, 311263, 311166, 311408, 303426
Quantity: 15 devices

The hazard

The FDA said the device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

Context

GovInfoNow's records show SenTec AG has four other recalls on record since May 2, 2019. Other recent recalls include a SenTec Membrane Changer recall on July 25, 2023, and a SenTec V-Sign Sensor 2 recall on May 2, 2023.

How to tell if you have this one

Check the serial number on your monitor. Affected units have serial numbers: 303170, 311263, 311166, 311408, 303426.

Brand
SenT:ec
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Isolation Transformer
Ensure your monitor has an isolation transformer for home use to meet safety standards.

Where it went and when

Where it was distributed

Distributed in 6 states.

FDA distribution: “IL, PA, FL, NJ, GA, MA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Georgia, Illinois, Massachusetts, New Jersey, Pennsylvania.

Recall timeline

FDA published this recall 2 months after the firm started it.

Dec 10, 2020Firm started the recall
Feb 18, 2021FDA classified it Class II
Feb 24, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63692-sentec-sdm-patient-monitor-requires-isolation-transformer-for-safe-home">SenTec SDM Patient Monitor: Requires Isolation Transformer for Safe Home Use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1134-2021 (December 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1134-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.