Recall Z-2176-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracrania
| Date | May 10, 2011 (initiated Mar 3, 2011) |
| Status | Terminated |
| Reason | The anomaly that has been identified with the Optical Guidance Platform (OGP) software may not be always displaying the correct transfer date on the patient file. |
| Root cause | Software design |
| Action | The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated March 3, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the Optical Guidance Platform (OGP) Instructions For Use on Loading a treatment plan; before positioning the patient, compare the plan details loaded into the OGP with the plan details printed from the treatment planning systems; verify that the patient information, isocenter, gantry and couch angles are identical as requested in the Instruc |
| Quantity | 599 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071360 | OPTICAL GUIDANCE PLATFORM Varian Medical Systems, Inc., Jun 8, 2007 |