Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient p
FDA device recall Z-0526-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc tion assembly cable and the ground stud on the lid of the High Voltage Module.
- Action taken
- Varian will work with affected customers to establish schedules that minimize impact to their clinic's treatment schedule and send Field Service Engineers with the required hardware to each affected site to make the modification.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 32 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-04-30
- Date posted
- 2014-12-16
- Date terminated
- 2015-03-16
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ON-BOARD IMAGER DEVICE (K042720) | Varian Medical Systems | 2004-10-29 |