ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
FDA Recall Z-1707-2014 · Posted 2014-06-03
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Recalling FirmBrainlab AG
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-04-15
Date Terminated2017-04-24
Product Quantity40 systems (worldwide)
Reason for Recall
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
Firm Action
Brainlab sent a "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letter dated March 13, 2014 was sent to all affected customers. The letter identifies the affected product, problem, and actions to be taken. The letter includes specific instructions to users that are intended to reduce the likelihood of similar events occurring when using ExacTrac software version 5.5.5. The letter further states that Brainlab will be providing a software update to all customers. Brainlab will contact all customers to arrange for the software update within the following 6 months.
Customers with any questions about this issue can contact Brainlab at 800-597-5911 or via e-mail at [email protected].
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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