Impac Medical Systems Inc 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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).

Recommended Action

Per FDA guidance

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

As reported by FDA

AL, CA, CT, FL, GA, IL, IA, KY, MI, MN, MS, NJ, ND, OH, OR, PA, TN, TX, VA, WA, WV, WI