Reported Feb 24, 2021 · Ongoing
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive…
SenTec AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SenTec AG · Ringstrasse 39 · Therwil, N/A · N/A
Is this the product you have?
- SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).
- Lot codes and dates
- Serial Numbers303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date
- Amount recalled
- 15 devices
Where it was sold
Why it was recalled
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
This product could cause temporary or reversible health problems — stop using it.
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