Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured
FDA device recall Z-2224-2011 · posted 2011-05-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.
- Action taken
- 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 of any coolant leakage. Varian was to contact customers to arrange for inspection if one had not been performed. The appropriate personnel should have been advised of the content of the letter. If further clarification was needed, customers were to contact their local Varian Customer Support.
- Root cause
- Process design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 718 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-03-31
- Date posted
- 2011-05-20
- Date terminated
- 2012-03-13
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890) | Varian Medical Systems | 2010-07-13 |