Data Foundry

Medical device recalls 2012

Finapres Medical Systems Portapres with NiMh battery pack Product… — Class II medical device recall Z-2150-2012

Terminated recall by FMS, Finapres Medical Systems BV, reported 2012-08-15, distributed nationwide. Battery may become hot and leak

Recall numberZ-2150-2012
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmFMS, Finapres Medical Systems BV, Amsterdam, Netherlands
Recall initiated2012-07-06
Classified2012-08-06
Reported by FDA2012-08-15
Terminated2012-09-12
DistributedNationwide (US)
Quantity3 units
Reason classespackaging
Serial numbers006, 008, 013

Product

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.

Reason for recall

Battery may become hot and leak

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2150-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.