Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2150-2012

July 06, 2012

Class II

Product summary

Firm
FMS, Finapres Medical Systems BV
Event
Event 62556
Status
Terminated
Classification
Class II
Quantity
3 units US
Official record key
device-enforcement:Z-2150-2012

Official wording

Reason: Battery may become hot and leak

Code information: Serial Numbers: 12 02 006, 12 02 008, 12 02 013

Distribution pattern: US Nationwide Distribution - including the states of: OH and NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Battery may become hot and leak