The Recall Desk
HighFDA (Devices)·Z-2150-2012·Announced 2012-08-15

Finapres Portapres Blood Pressure Monitor Recalled for Battery Safety

Finapres Medical Systems is recalling three Portapres blood pressure monitors in the US because the NiMh battery pack may become hot and leak.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (battery overheating/leaking) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Finapres Medical Systems BV is recalling three units of the Portapres blood pressure monitor in the United States. The recall is due to a safety hazard where the device's NiMh battery pack may become hot and leak.

The affected devices were distributed nationwide, including in Ohio and New York. The specific serial numbers for the recalled units are 12 02 006, 12 02 008, and 12 02 013. The Portapres is used to continuously measure blood pressure and can be worn on the body with a protective waist belt.

Consumers who possess these specific serial numbers should stop using the device and contact the recalling firm for instructions on how to proceed.

The recalled product

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.
Manufacturer
FMS, Finapres Medical Systems BV
Category
Medical Device — Blood Pressure Monitor
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Serial Numbers: 12 02 006
  • 12 02 008
  • 12 02 013

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same hazard · battery overheating

See all →