4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Varian Medial Systems, Palo Alto, CA De
FDA device recall Z-0932-2011 · posted 2011-01-21 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment, but the 4DITC software does not recognize that mulitplex isocenter is present.
- Action taken
- Urgent Medical Device Correction/Field Safety notification letters were distributed to all affected users, and to Varian Sales, Marketing and Service Organizations on December 14, 2010 by certified mail. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letters described the issue and recommended user actions along with Varian's actions. Users are to use caution when acquiring actual couch positions for any plan. In addition, each plan should be reviewed for quality assurance purposes in accordance to set departmental or organizational policies. The firm updated the procedure and enclosed a copy with the letter. It was also posted to the customer support site. If further clarification is needed, customers are to contact their local Varian Customer Support District or Regional Manager.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 4188
- Distribution
- Worldwide Distribution.
- Date initiated
- 2010-12-14
- Date posted
- 2011-01-21
- Date terminated
- 2011-07-22
- 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 |
|---|---|---|
| 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) (K081036) | Varian Medical Systems, Inc. | 2008-05-09 |