Recall Z-0713-05 ยท JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Fischer Imaging Corporation
Bloom DTU-215-B Programmable Stimulator
| Date | Apr 19, 2005 (initiated Jan 13, 2005) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991293 | EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR Fischer Medical Technologies, Inc., May 5, 2000 |