FDA Medical Device Recalls (openFDA)
Biotronik Inc: Belos VR Implantable Cardioverter Defibrillator
- Recall number
- Z-0074-04
- Recalling firm
- Biotronik Inc
- Product
- Belos VR 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
- 54 devices
- Distribution
- The firm distributes to physicians located throughout the US.
- Lot, serial or model codes
- Serial Numbers: 78112903, 78112904, 78112905, 78112906, 78112907, 78112908, 78112909, 78113004, 78113012, 78113013, 78113014, 78113015, 78113016, 78113017, 78113018, 78113019, 78113020, 78113022, 78113054, 78113055, 78113057, 78113058, 78113059, 78113060, 78113061, 78113062, 78113063, 78113064, 78113066, 78113067, 78113071, 78113082, 78113084, 78113085, 78113086, 78113090, 78113091, 78113092, 78113093, 78113094, 78113095, 78113096, 78113113, 78113114, 78113115, 78113116, 78113117, 78113118, 78113119, 78113120, 78113121, 78113122, 78113123, 78113124.
- 510(k) numbers
- not on file
- PMA numbers
- ["P980023/S4"]
- 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