Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)
This recall has been terminated (originally issued November 16, 2006).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- August 31, 2006
- Posted
- November 16, 2006
- Terminated
- December 4, 2007
- Recall Number
- Z-0194-2007
- Quantity
- 254 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The chain holding the device gantry in position may break.
Distribution
Worldwide, including USA, England, Taiwan, Switzerland, Sweden, South Korea, Portugal, Poland, Norway, New Zealand, Netherlands, Malaysia, Japan, Italy, Germany, France, Denmark, Czech Republic, Colombia, China, Canada, Belgium, Australia and Venezuela.
Lot / Code Info
Serial numbers H272325, H291060, H271879, H273040, H272187, H272434
Root Cause
Process control
Action Taken
On 8/31/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
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