Recall Z-0516-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo Alto, CA. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment.
| Date | Jan 11, 2012 (initiated Nov 23, 2011) |
| Status | Terminated |
| Reason | An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images. |
| Root cause | Software design |
| Action | The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" dated December 1, 2011 to all affected sites via Certified mail, return receipt. Canadian accounts were sent by Fed Ex and internationally to Varian International Customer Support Managers for translation and notification of customers. The notice described the product, problem and actions to be taken. The customers were instructed to always acquire both the treatment port and the open port images BEFORE displaying the digital graticule, when using a standard double exposure template; and to |
| Quantity | 1486 devices |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France,, Georgia, Germany,Greece, Hong Kong, Hungary |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091209 | PORTALVISION ADVANCED IMAGING Varian Medical Systems, Inc., Jun 23, 2009 |