Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; Reference/FSCA Id
FDA device recall Z-0736-2012 · posted 2012-01-13 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An anomaly has been identified with the Eclipse Treatment Planning System when planning for the Siemens Multileaf Collimator (MLC) where a virtual jaw can be positioned inside the MLC aperture and then used as the beam limiting device for the dose calculation. This will result in an incorrect dose distribution within Eclipse.
- Action taken
- Varian Medical Systems sent a Urgent Medical Device Correction letter dated December 12, 2011, to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to pay careful attention to any warnings displayed regarding the Virtual Collimator Jaws when the plan is calculated. If the warning indicates that the Virtual Collimator Jaws are inside the MLC aperture, do not proceed with the calculation. Varian is continuing to evaluate possible technical solutions for this issue. Special Instructions for customers outside the USA and Canada: In order to satisfy regulatory requirements, we request that you complete the attached Proof of Notification or Receipt Verification Card once you have read this document and return it to Varian Medical Systems. "We sincerely apologize for any inconvenience and thank you in advance for your cooperation." Please call for USA and Canada: 1.888.VARIAN5 (888.827.4265) Europe: +41 41 749 8844.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 11807 units, ***12-12-12 Amended to: 13, 616 units***
- Distribution
- Class II Recall - Worldwide Distribution -- USA (nationwide) including the countries of Canada and Europe.
- Date initiated
- 2011-12-12
- Date posted
- 2012-01-13
- Date terminated
- 2014-08-15
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECLIPSE TREATMENT PLANNING SYSTEM (K102011) | Varian Medical Systems, Inc. | 2010-09-03 |