Recall Z-0194-2007 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
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)
| Date | Nov 16, 2006 (initiated Aug 31, 2006) |
| Status | Terminated |
| Reason | The chain holding the device gantry in position may break. |
| Root cause | Process control |
| 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. |
| Quantity | 254 units |
| 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. |
| FDA record | Open on fda.gov |