CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report
V-Sign Membrane Changer Insert recalled by Sentec AG
Sentec AG is recalling SenTec V-Sign Membrane Changer Insert (Vs-mci) The SenTec V-Sign Membrane Changer Insert, distributed in Missouri. The recall was initiated on 5 Nov 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0434-2013
- FDA event ID
- 63631
- Recalling firm
- Sentec AG, Therwil, Baselland, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2012
- FDA classified
- 22 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 5 Nov 2012 | Recall initiated by company | |
| 22 Nov 2012 | Classified by FDA | +17 days |
| 28 Nov 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
SenTec 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 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.
Where it was distributed
Distributed only in MO.
Questions about this recall
Is V-Sign Membrane Changer Insert (Vs-mci) The SenTec V-Sign Membrane Changer Insert is recalled?
Yes. Sentec AG recalled V-Sign Membrane Changer Insert (Vs-mci) The SenTec V-Sign Membrane Changer Insert is on 5 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0434-2013.
Why was it 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.
Which lots are affected?
Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F
Where was it sold?
Distributed only in MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sentec AG
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Membrane Changer Single-Use recalled by SenTec AG | SenTec AG | Packaging Defects | Nationwide |
| Device | CLASS II | V-Sign Sensor recalled by SenTec AG | SenTec AG | Device Malfunction | Nationwide |
| Device | CLASS II | 24 / MARe-SF Multi-Site Attachment Ring Easy recalled by SenTec AG | SenTec AG | Other | Nationwide |
| Device | CLASS II | Digital Monitor recalled by SenTec AG | SenTec AG | Device Malfunction | 6 states |
| Device | CLASS II | Membrane Changer Insert [ recalled by SenTec AG | SenTec AG | Device Malfunction | Nationwide |
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| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |