03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [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. [Code Info] Serial Numbers: 12 02 006, 12 02 008, 12 02 013 [Reason for Recall] Battery may become hot and leak [Recalling Firm] FMS, Finapres Medical Systems BV [Classification] 
Class II
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Enforcement Report - Week of August 15, 2012