510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-0855-2009

Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48...

Varian Medical Systems, Inc. / initiated 2008-10-02 / Terminated / root cause: software
FDA source (opens on fda.gov)

Varian Medical Systems Oncology Systems began a recall of Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo... on . The reason FDA records is "When using the multiple static segment option, the device may alter dose delivery". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0855-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Varian Medical Systems, Inc.
Product
Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. Indicated for planning proton treatment of neoplasms of the eye.
Product code
MUJ System, Planning, Radiation Therapy Treatment
Reason for recall
When using the multiple static segment option, the device may alter dose delivery.
Root cause tag
software
FDA root cause
Software design
Action
An Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps on October 2, 2008. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm recommends that customers DO NOT USE the Multiple Static Segment (MSS) option in Varian Leaf Motion Calculator version 8.2.22. The firm also recommends setting the default delivery method for Varian Leaf Motion Calculator to Sliding Window. When using Eclipse 8.5, always follow the Safety Instructions found in chapter 2 of "Eclipse External Beam Planning Instruction for Use", P/N B501357R01A, March 2008. If customers believe a patient treatment has been affected by this issue, they should notify a Varian Service or Support person as soon as possible.
Quantity in commerce
64 units
Distribution
Worldwide Distribution --- including USA and countries of Switzerland and the Netherlands.
Product codes and lots
Model number H48, serial numbers H480016, H480051, H480052, H480053, H480054, H480055, H480107, H480133, H480293, H480346, H480347, H480472, H480652, H480920, H481467, H481510, H481639, H481724, H481807, H481815, H481816, H481912, H481913, H481914, H481915, H482194, H482195, H482289, H482793, H482807, H483204, H483407, H484367, H484635, H484636, H484637, H484638, H484781, H484864, H485100, H485125, H485244, H485346, H485466, H485729, H486858, H486859, H486860, H486861, H486946, H486947, H486948, H487190, H487212, H487414, H487580, H487581, H487623, H487640, H487641, H487642, H487700, and H487757.