Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Acceler
FDA device recall Z-1195-2007 · posted 2007-08-29 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- Patient positioning errors may occur because of mechanical variations during product installation.
- Action taken
- The firm issued a notification letter to all customers April 18, 2007. The firm intends to arrange for service personnel to contact affected sites to verify the calibration of the OBI system, and make arrangements to correct any issues. The firm will also update installation manuals to clearly describe the OBI installation and calibration requirements.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 291 units
- Distribution
- Worldwide, including USA, Puerto Rico, Australia, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Italy, Japan, Luxembourg, New Zealand, Norway, Po
- Date initiated
- 2007-04-18
- Date posted
- 2007-08-29
- Date terminated
- 2010-08-12
- Location
- Palo Alto, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ON-BOARD IMAGER DEVICE (K042720) | Varian Medical Systems | 2004-10-29 |
| MODIFICATION TO: ON-BOARD IMAGER DEVICE (K041519) | Varian Medical Systems, Inc. | 2004-08-04 |
| ON-BOARD IMAGER DEVICE (K040192) | Varian Medical Systems, Inc. | 2004-02-27 |