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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Product Detail

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.
Recall Number Z-2150-2012
Classification Class II
Code Info Serial Numbers: 12 02 006, 12 02 008, 12 02 013
Product Distributed Qty 3 units US
Reason For Recall Battery may become hot and leak

Event Detail

Event Id 62556
Product Type Devices
Status Ongoing
Recalling Firm FMS, Finapres Medical Systems BV
City Amsterdam
Country NL
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution - including the states of: OH and NY