Class 2 Device Recall MOSAIQ

• Date Initiated by Firm: July 17, 2009
• Date Posted: August 21, 2009
• Recall Status: Terminated on November 25, 2011
• Recall Number: Z-1027-2011
• Recall Event ID: 52903
• 510(K)Number: K981313
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA.; The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment machine. SEQUENCER provides the capability to notify the users of actions that need to take place prior to treatment, to display reference images for set up purposes, and to auto setup the machine to predefined settings. Actual settings are read from the treatment machine, via the machine's communication interface, and compared to the predefined values. If a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate times during the treatment, the actual delivered values are recorded to provide treatment tracking. Treatments are initiated by the operator, via the machine control system, only after the user has verified that the treatment setup is correct. SEQUENCER does not bypass any checks put in place by the machine's control system.
• Code Information: MOSAIQ version 1.30 (all builds), MOSAIQ version 1.40 (all builds), MOSAIQ version 1.50 (all builds), MOSAIQ version 1.60 (all builds, and MOSAIQ version 2.0 (all builds).
• Recalling Firm/ Manufacturer: Impac Medical Systems Inc; 100 Mathilda Pl Fl 5th; Sunnyvale CA 94086-6076
• For Additional Information Contact: 408-830-8007
• Manufacturer 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).
• FDA Determined Cause: Software design
• Action: 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.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.