FDA Enforcement
Class II
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
·
Reported August 15, 2012
Enforcement
- Recall Number
- Z-2150-2012
- Event ID
- 62556
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- FMS, Finapres Medical Systems BV
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 15, 2012
- Initiation Date
- July 6, 2012
- Classification Date
- August 6, 2012
- Termination Date
- September 12, 2012
- Address
- Paasheuvelweg 34A, 1105 BJ, Amsterdam, N/A, Netherlands
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
Code Info
Serial Numbers: 12 02 006, 12 02 008, 12 02 013
Distribution
US Nationwide Distribution - including the states of: OH and NY
Quantity
3 units US