FDA Medical Device Recalls (openFDA)
Biotronik Inc: Belos VR-T Implantable Cardioverter Defibrillator
- Recall number
- Z-0075-04
- Recalling firm
- Biotronik Inc
- Product
- Belos VR-T Implantable Cardioverter Defibrillator
- Status
- Terminated
- Initiated
- 2003-09-24
- Posted
- 2003-10-31
- Terminated
- 2005-02-28
- Reason
- Potential extended charge time anomalies.
- Root cause
- Other
- Action
- Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up with affected patients.
- Quantity
- 8 devices
- Distribution
- The firm distributes to physicians located throughout the US.
- Lot, serial or model codes
- Serial Numbers: 78140141, 78140145, 78140146, 78140147, 78140148, 78140150, 78140151, 78140152.
- 510(k) numbers
- not on file
- PMA numbers
- ["P980023/S8"]
- Product code
- LWS
- Firm FEI
- 1028232
- Firm city
- Lake Oswego
- Firm state
- OR
- Firm country
- not on file
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