RecallRadar

FDA Device recall Z-2150-2012

Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on…

On 2012-08-15 the FDA classified a Class II recall of Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on… by Fms Finapres Medical Systems Bv, citing battery may become hot and leak.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2150-2012
ClassificationClass II
Statusterminated
Initiated2012-07-06
Published2012-08-15
Last updated2026-09-13 11:53 UTC
CompanyFms Finapres Medical Systems Bv
DistributionUS

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

Battery may become hot and leak

Identifiers

code_infoSerial Numbers: 12 02 006, 12 02 008, 12 02 013

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2150-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.