Z-1134-2021 Class II Ongoing
FDA device recall Z-1134-2021 was initiated by SenTec AG on December 10, 2020 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 15 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- December 10, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 devices
Product Description
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).
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 Pattern
IL, PA, FL, NJ, GA, MA
Code Information
Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date