CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report
Finapres Medical Systems Portapres with NiMh battery pack recalled
FMS, Finapres Medical Systems BV is recalling Finapres Medical Systems Portapres with NiMh battery pack, distributed nationwide in the US. The recall was initiated on 6 Jul 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-2150-2012
- FDA event ID
- 62556
- Recalling firm
- FMS, Finapres Medical Systems BV, Amsterdam
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jul 2012
- FDA classified
- 6 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 6 Jul 2012 | Recall initiated by company | |
| 6 Aug 2012 | Classified by FDA | +31 days |
| 15 Aug 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Battery may become hot and leak
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.
Where it was distributed
US Nationwide Distribution - including the states of: OH and NY
Questions about this recall
Is Finapres Medical Systems Portapres with NiMh battery pack recalled?
Yes. FMS, Finapres Medical Systems BV recalled Finapres Medical Systems Portapres with NiMh battery pack on 6 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-2150-2012.
Why was it recalled?
Battery may become hot and leak
Which lots are affected?
Serial Numbers: 12 02 006, 12 02 008, 12 02 013
Where was it sold?
US Nationwide Distribution - including the states of: OH and NY
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.
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