Electrophysiology Imaging System
This recall has been terminated (originally issued September 9, 2005).
- Company
- Fischer Imaging Corporation
- Recall Initiated
- April 28, 2005
- Posted
- September 9, 2005
- Terminated
- March 13, 2012
- Recall Number
- Z-1525-05
- Quantity
- 51 units
- Firm Location
- Denver, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.
Distribution
Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
Lot / Code Info
Model ISS, Product Number 74600G-2 thru 9
Root Cause
Other
Action Taken
Consignees were notified by certified letter on 04/27/2005.
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