SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2

FDA device recall Z-1027-2011 · posted 2009-08-21 · Terminated

Recall details

Recalling firm

Impac Medical Systems Inc

Reason for recall

Potential for improper treatment. A software error may result in potential major underdosing to targeted areas from jaw blockage of the MLC aperture (jaw intrusion), and dosing to non-targeted areas from interstitial leaf leakage (jaw extrusion).

Action taken

Impac Medical Systems Inc sent an Important Safety Notice letter to all affected consginees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Impact Software support as soon as possible if they have the affected configurations identified in the letter. Customers were asked to complete the form included with the letter and and fax to: European customers: +44 1293 654401 American & rest of world customers 702-992-5002 or e-mail to support@impac.com Customers were asked to distribute the Safety Notice to any and all users of IMPAC software at their organization who are potentially affected by this issue. For questions e-mail support@impac.com or call European customers: 44 1293 654320 American & rest of world customers: 800-488-4672.

Root cause

Software design

Status

Terminated

Product code

IYE

Distribution

Worldwide Distribution - USA including AL, CA, CT, FL, GA, IA, IL, KY, MI, MN, MS, ND, NJ, OH, OR, PA,TN, TX, VA, WA, WI, and WV and the country of Canada.

Date initiated

2009-07-17

Date posted

2009-08-21

Date terminated

2011-11-25

Location

Sunnyvale, CA

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