Bloom DTU-215-B Programmable Stimulator
This recall has been terminated (originally issued April 19, 2005).
- Company
- Fischer Imaging Corporation
- Recall Initiated
- January 13, 2005
- Posted
- April 19, 2005
- Terminated
- March 13, 2012
- Recall Number
- Z-0713-05
- Quantity
- 712 units
- Firm Location
- Denver, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
Distribution
Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.
Lot / Code Info
All Bloom DTU-215-B Programmable Stimulators.
Root Cause
Other
Action Taken
Customers were notified by letter on 01/13/05.
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