VersaRad Generator
This recall has been terminated (originally issued May 3, 2005).
- Company
- Fischer Imaging Corporation
- Recall Initiated
- September 30, 2004
- Posted
- May 3, 2005
- Terminated
- March 13, 2012
- Recall Number
- Z-0787-05
- Quantity
- 38 units
- Firm Location
- Denver, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Some VersaRad Systems have a faulty weld that may result in oil leakage.
Distribution
Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities.
Lot / Code Info
Generator S/N''s: 9918-0704-002; 9918-0804-003; 9918-0804-007; 9918-0804-005; 9918-0204-001; 9918-0304-001; 9918-0304-003; 9918-03304-004; 9918-0505-002; 9918-0604-001; 9918-0604-003; 9918-0604-006; 9918-0704-001; 9918-0704-003; 9918-0704-004; 9918-0704-005; 9918-0803-002; 9918-0804-002; 9918-0903-002; 9918-1003-001; 9918-1203-002; 9918-0604-007; 9918-0804-004; 9918-0404-002; 9918-0803-001; 9918-0504-003; 0304-002; 0404-003; 0504-004; 9918-0604-005; 9918-0903-001; 9918-0404-001; 9918-0604-002; 9918-0504-001; 9918-0804-001; 9918-1103-001; 9918-1203-001; 9918-0604-004.
Root Cause
Other
Action Taken
Customers were sent notification letters.