XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatment plans for any cancer patient

FDA device recall Z-1644-2012 · posted 2012-05-22 · Terminated

Recall details

Recalling firm

Computerized Medical Systems Inc

Reason for recall

XiO will underestimate the dose delivered when the closed leaf gap is set to 0mm on XiO and a value other than 0mm is set on the accelerator.

Action taken

Computerized Medical Systems, Inc. sent an Important Safety Notice the week of April 30, 2012, by regional support managers via e-mail, fax, or regular mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. North American customers were instructed to go to www.elekta.com, select the SupportPlus Login at the top of the page, enter their portal, select Downloads/Updates to download the latest patches. For Customers outside North America, go to www.elekta.com, select the SOFTWARE button on the left, Treatment Planning Software, then Contact TPS Support tab, Download TPS Software Patches. ............................................................. Customers were also instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue. For questions regarding this recall call 408-380-8023.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

1,652 sites received the versions

Distribution

Worldwide Distribution - USA (nationwide) and the country of Canada

Date initiated

2012-04-30

Date posted

2012-05-22

Date terminated

2014-04-01

Location

Maryland Heights, MO

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