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)
FDA Recall Z-0194-2007 · Posted 2006-11-16
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Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2006-08-31
Date Terminated2007-12-04
Product Quantity254 units
Reason for Recall
The chain holding the device gantry in position may break.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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