Bloom DTU-215-B Programmable Stimulator
FDA device recall Z-0713-05 · posted 2005-04-19 · Terminated
Recall details
- Recalling firm
- Fischer Imaging Corporation
- Reason for recall
- Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
- Action taken
- Customers were notified by letter on 01/13/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOQ
- Quantity affected
- 712 units
- Distribution
- Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.
- Date initiated
- 2005-01-13
- Date posted
- 2005-04-19
- Date terminated
- 2012-03-13
- Location
- Denver, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR (K991293) | Fischer Medical Technologies, Inc. | 2000-05-05 |