Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is man
FDA device recall Z-2176-2011 · posted 2011-05-10 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- 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.
- Action taken
- 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 Instructions For Use, and advise the appropriate personnel working in their radiotherapy department of the content of this recall letter. Varian has made changes to the OGP Instructions For Use -Varian strongly recommends you download the most recent version at www.MyVarian.com or request a copy from your local Varian Customer Support District or Regional Manager. Varian also is preparing a software correction which will be applied to affected unites to correct this issue. If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager at the follow: USA and Canada - 1-888-827-4265; Europe +41 41 749 8844; E-mail-North America: support-americas@varian.com; Australia/New Zealand: support.anz@varian.com; Europe: support-emca@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.Apps.Helpdesk@varian.com, and Latin America: soporte.al@varian.com; Internet: Oncology Systems customer site - www.myvarian.com and Varian Medical Systems public site-www.varian.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 599 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2011-03-03
- Date posted
- 2011-05-10
- Date terminated
- 2012-06-19
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTICAL GUIDANCE PLATFORM (K071360) | Varian Medical Systems, Inc. | 2007-06-08 |