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SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for contin...

FDA Recall #Z-1134-2021 — Class II — December 10, 2020

Recall #Z-1134-2021 Date: December 10, 2020 Classification: Class II Status: Ongoing

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.

Recalling Firm

SenTec AG — Therwil, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

15 devices

Distribution

IL, PA, FL, NJ, GA, MA

Code Information

Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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