Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The Ali
FDA device recall Z-2149-2016 · posted 2016-07-11 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
- Action taken
- The firm, Visionrt, sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION-URGENT FIELD SAFETY NOTIFICATION" letter dated June 24, 2016 to all affected customers. Letters describe the product, problem and actions to be taken. The customers were instructed as follows: DO NOT USE the "Move Couch" function if the couch rotation value set in the AlignRT device DOES NOT match the planned couch rotation for the treatment field; retain a copy of this document along with your most current product labeling; pass the letter to all those who need to be aware of it within their organization; always confirm that the patient is correctly aligned prior to commencing treatment; is not required to return their devices; promptly inform Vision RT if they believe that patient harm occurred, and complete Appendix 1- Customer Acknowledgment Response and return it via email to corrections@visionrt.com. Should you have any queries on this letter, please do not hesitate to contact Vision RT by telephone on +44 20 83464300 (866-778-2379 from the US) or as per http://www.visionrt.com/contact/details.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 166 OSMS in US, 23 OSMO - International,
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, a
- Date initiated
- 2016-06-23
- Date posted
- 2016-07-11
- Date terminated
- 2018-08-24
- 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 |
|---|---|---|
| ALIGNRT PLUS (K123371) | Vision RT Limited | 2013-01-08 |