SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The… recallZ-0433-2013 · Sentec AG · initiated Nov 5, 2012
Class II Terminated All recalls posted in November 2012
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
A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.
FDA root cause category: Component design/selection
What the company is doing
SenTec notified the one US distributor via e-mail on November 5, 2012. The distributor was advised to stop distribution of affected lot numbers. The communication to the distributor described the issue, identified affected product, and stated that SenTec will replace current stock at the end-customer level. The end user can discard the affected products. The distributor is asked to respond back with an e-mail to SenTec that they took appropriate action.
Recall details
- Recall number
- Z-0433-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 5, 2012
- Posted by the FDA
- Nov 22, 2012
- Recalling firm
- Sentec AG
- Quantity
- 195 boxes (9 per box)
- Product code
- LKD
- FDA submissions
- K101690
- Distribution
- Distributed only in MO.
Product description
SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.
Code information (models, lots, serial numbers)
Lot numbers: 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D
Other devices under the same FDA submission
6 devices cleared under K101690 — 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
Other products in the same recall event
The FDA groups related products into one recall event (event 63631).
- Z-0434-2013 · TerminatedSenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor …
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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