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Terminated

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.

FDA Recall Z-1027-2011 · Posted 2009-08-21

Recalling FirmImpac Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-07-17
Date Terminated2011-11-25

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).

Firm 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 [email protected] 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 [email protected] or call European customers: 44 1293 654320 American & rest of world customers: 800-488-4672.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981313SEQUENCERImpac Medical Systems, Inc. · 1998-07-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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