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U.S. Department of Health and Human Services

Class 2 Device Recall Finapres Portapres Ambulatory Continuous NonInvasive Blood Pressure Monitor

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 Class 2 Device Recall Finapres Portapres Ambulatory Continuous NonInvasive Blood Pressure Monitorsee related information
Date Initiated by FirmJuly 06, 2012
Date PostedAugust 06, 2012
Recall Status1 Terminated 3 on September 12, 2012
Recall NumberZ-2150-2012
Recall Event ID 62556
510(K)NumberK023338 
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
ProductFinapres 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 Information Serial Numbers: 12 02 006, 12 02 008, 12 02 013
Recalling Firm/
Manufacturer		 FMS, Finapres Medical Systems BV
Paasheuvelweg 34A
1105 BJ
Amsterdam Netherlands
For Additional Information ContactJoe Farnsworth
207-9560292
Manufacturer Reason
for Recall		Battery may become hot and leak
FDA Determined
Cause 2		Process control
ActionFinapres 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 info@finapres.com.
Quantity in Commerce3 units US
DistributionUS Nationwide Distribution - including the states of: OH and NY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DXN
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