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).
- Recall Initiated
- December 10, 2020
- Recall Number
- Z-1134-2021
- Quantity
- 15 devices
Reason for Recall
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Distribution
IL, PA, FL, NJ, GA, MA
Lot / Code Info
Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date
Root Cause
Device Design
Action Taken
The firm initiated their correction by letter to the direct accounts on 12/10/2020. The letter explains the problem and provides additional instruction manuals and a sticker to address the use of the product in the home care environment.
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