SDMS (SenTec Digital Monitoring System) recallZ-0088-2017 · SenTec AG · initiated Sep 15, 2016
Class II Terminated All recalls posted in October 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SenTec AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).
FDA root cause category: Component change control
What the company is doing
Distributors were sent via e-mail a SenTec 'Mandatory initiated field correction action" letter dated September 15, 2016 . The letter provided a "Description of the issue, Affected products, Identify and localize affected products, Removal from use, Replacement of affected products at end customer & distributor / sub-distributor level". It also provided "action information for sub-distributors and affiliates, and end customers". For questions contact SenTec Inc. by e-mail ([email protected]) or phone (636-343-0000).
Recall details
- Recall number
- Z-0088-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 15, 2016
- Posted by the FDA
- Oct 17, 2016
- Recalling firm
- SenTec AG
- Quantity
- 75 (54 US; 21 =OUS)
- Product code
- LKD
- FDA submissions
- K041548, K071672, K101690, K151329
- Distribution
- Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.
Product description
SDMS (SenTec Digital Monitoring System)
Code information (models, lots, serial numbers)
SN 306497 to SN 306571.
Other devices under the same FDA submission
6 devices cleared under K041548, K071672, K101690, K151329 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Membrane Changer (reloadable) / single unit MC-RSenTec AG · Oximeter, Ear1 recall0 reports
- Membrane Changer Inserts MC-ISenTec AG · Oximeter, Ear1 recall0 reports
- V-Sign™ Sensor 2 VS-A/P/NSenTec AG · Oximeter, Ear1 recall0 reports
- Membrane Changer (single-use) / single unit MCSenTec AG · Oximeter, Ear1 recall0 reports
- Sentec Digital Monitor SDMSenTec AG · Oximeter, Ear1 report
- Multi-Site Attachment Ring for mature/intact skin MARe-MISenTec AG · Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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