FDA Medical Device Recalls (openFDA)
Fischer Imaging Corporation: Bloom DTU-215-B Programmable Stimulator
- Recall number
- Z-0713-05
- Recalling firm
- Fischer Imaging Corporation
- Product
- Bloom DTU-215-B Programmable Stimulator
- Status
- Terminated
- Initiated
- 2005-01-13
- Posted
- 2005-04-19
- Terminated
- 2012-03-13
- Reason
- Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
- Root cause
- Other
- Action
- Customers were notified by letter on 01/13/05.
- Quantity
- 712 units
- Distribution
- Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.
- Lot, serial or model codes
- All Bloom DTU-215-B Programmable Stimulators.
- 510(k) numbers
- ["K991293"]
- PMA numbers
- not on file
- Product code
- JOQ
- Firm FEI
- 1418957
- Firm city
- Denver
- Firm state
- CO
- 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