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Terminated

iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

FDA Recall Z-0956-2015 · Posted 2015-01-15

Recalling FirmBrainlab AG
Recall StatusTerminated
Product CodeMUJ
Date Initiated2014-11-19
Date Terminated2018-03-28
Product Quantity1,412 systems total

Reason for Recall

iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.

Firm Action

Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 19, 2014, to all affected customers. The letter included instructions to: 1) If clinically not required, do not use multiple localized CT scans within one treatment plan (to avoid potentially incorrect Reference and Alignment Set assignments in the first place). 2) If you must use multiple localized CT scans, e.g. for recurrent treatment planning of the same patient, always guarantee that the latest (see note *) CT scan is defined as both Alignment Set and Reference Set during treatment planning. Brainlab will provide a software solution to prevent the described scenario from occurring. Brainlab will actively contact affected customers tentatively starting January 2016 to schedule the update. Brainlab will additionally refine the instructions for use of the iPlan RT treatment planning software in regard to implications of Alignment Set and Reference Set selections and will provide this user guide update to existing affected customers together with the software update. Customers with questions can contact Brainlab at 800-597-5911 or via e-mail at [email protected].

Root Cause

Software in the Use Environment

Distribution Pattern

Worldwide Distribution - USA including Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, Wyoming and Internationally to Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103246IPLAN RTBrainlab AG · 2011-03-16K080888MODEIFICATION TO IPLAN RT DOSEBrainlab AG · 2008-06-11K053584IPLAN RT DOSEBrainlab AG · 2006-07-12

Official Source

View FDA Recall →

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

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