FDA Medical Device Recalls (openFDA)
FMS, Finapres Medical Systems BV: 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
- Recalling firm
- FMS, Finapres Medical Systems BV
- 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.
- Status
- Terminated
- Initiated
- 2012-07-06
- Posted
- 2012-08-06
- Terminated
- 2012-09-12
- Reason
- Battery may become hot and leak
- 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 info@finapres.com.
- Quantity
- 3 units US
- Distribution
- US Nationwide Distribution - including the states of: OH and NY
- Lot, serial or model codes
- Serial Numbers: 12 02 006, 12 02 008, 12 02 013
- 510(k) numbers
- ["K023338"]
- PMA numbers
- not on file
- Product code
- DXN
- Firm FEI
- 3003803088
- Firm city
- Amsterdam
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28