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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 Monitor see related information
Date Initiated by Firm July 06, 2012
Date Posted August 06, 2012
Recall Status1 Terminated 3 on September 12, 2012
Recall Number Z-2150-2012
Recall Event ID 62556
510(K)Number K023338  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product 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 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 Contact Joe Farnsworth
207-9560292
Manufacturer Reason
for Recall		 Battery may become hot and leak
FDA Determined
Cause 2		 Process control
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 info@finapres.com.
Quantity in Commerce 3 units US
Distribution US Nationwide Distribution - including the states of: OH and NY
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DXN and Original Applicant = FMS, FINAPRES MEDICAL SYSTEMS BV
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