Z-2150-2012Class II

Finapres Medical Systems Portapres with NiMh battery pack

Name: Z-2150-2012 Finapres Medical Systems Portapres with NiMh battery pack
Creator: FMS, Finapres Medical Systems BV
Published: 2012-07-06
License: https://open.fda.gov/license/

Finapres Medical Systems B.V. / initiated 2012-07-06 / Terminated / root cause: manufacturing process

FDA source

FMS, Finapres Medical Systems BV began a recall of Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a... on 2012-07-06. FDA classified it as Class II and gives the reason as "Battery may become hot and leak". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2150-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-06
Posted: 2012-08-06
Terminated: 2012-09-12
Recalling firm: Finapres Medical Systems B.V.
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.
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: Battery may become hot and leak
Root cause tag: manufacturing process
FDA root cause: 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 [email protected].
Quantity in commerce: 3 units US
Distribution: US Nationwide Distribution - including the states of: OH and NY
Product codes and lots: Serial Numbers: 12 02 006, 12 02 008, 12 02 013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2150-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2150-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-06

Product code DXN

K023338Class IIPortapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,model-2Fms, Finapres Medical Systems BV / cleared 2003-05-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)