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Terminated

Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine, via the machines communication interface, and compared to predefined values. if a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate points during the treatment, the actual delivered values are recorded to provide treatment tracking.

FDA Recall Z-0052-2012 · Posted 2011-10-17

Recalling FirmImpac Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-09-09
Date Terminated2012-03-06
Product Quantity11 devices

Reason for Recall

Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.

Firm Action

" Impac Medical Systems Inc., sent an USER NOTICE letter to all affected consignees on September 20, 2011. The letters identified the source characterization error, clinical impact, and final resolution. The letter states that Elekta Support will follow up with each consignee and remotely correct the source characterization. Customers were instructed to sign, date and return the attached Confirmation of Receipt Form by one of the three ways indicated. The letter instructs consignees to distribute this notice to any and all users of IMPAC software that may potentially be affected by the issue. For questions, concerns, and requests for upgrade, email [email protected] or call. The letter provided consignees with a complete list of contact information..

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution (USA) - including the states of: AZ, CA, FL, NJ, NY, NV, TX, VA and WA.

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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