FDA Recall Terminated

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.

Recall: Z-2150-2012 · Initiated July 6, 2012

Recall

Recall Number
Z-2150-2012
Event Number
62556
Firm
FMS, Finapres Medical Systems BV Paasheuvelweg 34A 1105 BJ Amsterdam Netherlands
FEI Number
3003803088
Product Code
DXN
Status
Terminated
Root Cause
Process control
Initiated
July 6, 2012
Posted
August 6, 2012
Terminated
September 12, 2012

Description

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

Action

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 [email protected].

Distribution

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

Quantity

3 units US