FDA Medical Device Recalls (openFDA)
Biotronik Inc: Deikos A+
- Recall number
- Z-0944-04
- Recalling firm
- Biotronik Inc
- Product
- Deikos A+
- Status
- Terminated
- Initiated
- 2004-04-29
- Posted
- 2004-07-20
- Terminated
- 2006-04-21
- Reason
- Potential for device to not deliver full amount of energy
- Root cause
- Other
- Action
- On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated.
- Quantity
- 6
- Distribution
- Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
- Lot, serial or model codes
- Model Number 334 341 Serial numbers: 78062958, 78062960, 78062961, 78062962, 78062997, 78063002
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- 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