Varian Medical Systems Oncology Systems 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Varian Medical Systems Oncology Systems
Lot Codes / Batch Numbers
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.
Products Sold
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.
Varian Medical Systems Oncology Systems is recalling Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number due to When using the multiple static segment option, the device may alter dose delivery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When using the multiple static segment option, the device may alter dose delivery.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026