VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x
This recall has been terminated (originally issued March 12, 2003).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- January 31, 2003
- Posted
- March 12, 2003
- Terminated
- September 17, 2003
- Recall Number
- Z-0633-03
- Quantity
- 12 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.
Distribution
Product was released for distribution to 7 hospitals in the US. Distribution was limited to the following States: CA, MA, NC, SC, PA, and LA. 1 (one) Canadian distribution includes Fraser Valley Cancer Center, Dept. of Radiation Oncology, 13750 96th Ave., Surrey, BC, V3V 1Z2, Canada. Foreign distribution includes Austria, Germany and Finland. The recall was appropriately extended to the user level; i.e., the hospitals/physicians who received the recalled product.
Lot / Code Info
Affected Serial Numbers: 44, 260, 315, 495, 746, 751, 873, 907, 984, 1098, 1131, and 9045
Root Cause
Software design
Action Taken
On 1/16/03 and 2/4/03 (2nd notification) the firm initiated the recall and their notification was via letters to inform its consignees about the new VARiS version 6.2.27 release.