medical device and software systems
FDA device recall Z-1314-04 · posted 2004-08-07 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- 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.
- Action taken
- Notification letter to consignees sent 06/14/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 28 units
- Distribution
- produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign
- Date initiated
- 2004-06-24
- Date posted
- 2004-08-07
- Date terminated
- 2004-12-23
- Location
- Palo Alto, CA
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