Z-2150-2012 Class II Terminated
FDA device recall Z-2150-2012 was initiated by FMS, Finapres Medical Systems BV on July 6, 2012 and is designated Class II. Reason for recall: Battery may become hot and leak The recall status is terminated (terminated September 12, 2012). Affected quantity: 3 units US.
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2012
- Initiation Date
- July 6, 2012
- Termination Date
- September 12, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units US
Product 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 for Recall
Battery may become hot and leak
Distribution Pattern
US Nationwide Distribution - including the states of: OH and NY
Code Information
Serial Numbers: 12 02 006, 12 02 008, 12 02 013