SenTec Digital Monitor recall
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon…
Why was SenTec Digital Monitor recalled?
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date
- Product
- SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon…
- Recalling firm
- SenTec AG
- Quantity
- 15 devices
- Distribution
- IL, PA, FL, NJ, GA, MA
- Recall date
- February 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)