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.
FDA Recall Z-2150-2012 · Posted 2012-08-06
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Recalling FirmFMS, Finapres Medical Systems BV
Recall StatusTerminated
Product CodeDXN
Date Initiated2012-07-06
Date Terminated2012-09-12
Product Quantity3 units US
Reason for Recall
Battery may become hot and leak
Firm 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].
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution - including the states of: OH and NY
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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