FDA Device

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.

Hazard

Battery may become hot and leak

What You Should Do

Remedy

Finapres Medical Systems BV sent a Field Safety Notice letter dated July 6, 2012 to notified US accounts of the recall. The letter identified the affected product, description of the problem and actions to be taken. The letter states that the recalling firm recommends not using the affected battery packs. A replacement battery was included in shipment. Customers were requested to return recalled battery. For questions call +31 (0)20 609 0974 or email info@finapres.com.

Products

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 us
Brand
FMS, Finapres Medical Systems BV Paasheuvelweg 34A 1105 BJ Amsterdam Netherlands
UPC
Serial Numbers: 12 02 006, 12 02 008, 12 02 013

Units Affected

3 units US