Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian Medical Sys
FDA device recall Z-2200-2011 · posted 2011-05-16 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral offset error.
- Action taken
- On 3/30/2011, Varian distributed an Urgent Medical Device Correction Urgent Field Safety Notice to all affected users, with a description of the problem and identification of the affected product. The letter also informed customers of how they can determine if the problem affects them. The letter states that there is no work around for the issue unless they possess a FastPlan system. Varian is preparing a software patch to correct the issue and it will be applied to all OGP v2.6 and v2.6.1 systems. Customers are to advise the appropriate personnel of the content of the letter. 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
- 598 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-03-30
- Date posted
- 2011-05-16
- 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 |