medical device and software systems
This recall has been terminated (originally issued August 7, 2004).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- June 24, 2004
- Posted
- August 7, 2004
- Terminated
- December 23, 2004
- Recall Number
- Z-1314-04
- Quantity
- 28 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.
Distribution
produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign
Lot / Code Info
Version Numbers 6.2.27 and 6.2.35, 510k number K001643, serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045)
Root Cause
Other
Action Taken
Notification letter to consignees sent 06/14/2004.