Z-1134-2021Class II

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

Name: Z-1134-2021 SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous...
Creator: SenTec AG
Published: 2020-12-10
License: https://open.fda.gov/license/

Sentec AG / initiated 2020-12-10 / Open, Classified / root cause: design

FDA source

SenTec AG began a recall of SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial... on 2020-12-10. FDA classified it as Class II and gives the reason as "Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1134-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-10
Posted: 2021-02-18
Recalling firm: Sentec AG
Product: 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).
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 15 devices
Distribution: IL, PA, FL, NJ, GA, MA
Product codes and lots: Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1134-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1134-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-18

Product code LKD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)