Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system; Model: Low Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC -- Stereotactic motion disable Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA
This recall has been terminated (originally issued February 14, 2008).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- September 10, 2007
- Posted
- February 14, 2008
- Terminated
- November 27, 2010
- Recall Number
- Z-0545-2008
- Quantity
- 418 (total for Recalls Z-0544-0545-2008)
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.
Distribution
Worldwide- Canada, Mexico, and the USA
Lot / Code Info
The Serial Numbers: H180001, H180007, H180076, H180143, H180147, H180169, H180181, H180187, H180195, H180222, H180273, H180276, H180311, H180314, H180322, H180460, H180467, H180473, H180490, H180493, H180514, H180533, H180550, H180563, H180566, H180570, H180576, H180599, H180613, H180631, H180671, H180690, H180697, H180718, H180731, H180739, H180779, H180785, H180786, H180808, H180815, H180816, H180822, H180836, H180844, H180855, H180877, H180894, H181065, H180066, and H180769
Root Cause
Labeling design
Action Taken
On 9/10/07, the firm issued an Urgent Medical Device Correction letter to all its direct consignees, informing them of the device defect and providing instructions on the recall. Short term user instructions were provided and the firm will schedule follow-up visits to make the needed permanent device corrections at each device site.