Recall Z-2224-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
| Date | May 20, 2011 (initiated Mar 31, 2011) |
| Status | Terminated |
| Reason | The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing. |
| Root cause | Process design |
| Action | On 3/31/2011, all consignees were notified via an Urgent Medical Device Correction letter and on-site visit by the firm's sales representative, informing them of the affected products, the issue, and recommended actions. If non-Varian personnel service the device, then they should have been immediately notified of the content of the letter. Anyone who performs work on the device should exercise extreme care to identify any possible coolant leak and immediately locate and correct the source of the leak. Customers were to immediately notify Varian Service or their internal service personnel o |
| Quantity | 718 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100890 | VARIAN HIGH ENERGY LINEAR ACCELERATOR Varian Medical Systems, Jul 13, 2010 |