iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned,

FDA device recall Z-0957-2015 · posted 2015-01-15 · Terminated

Recall details

Recalling firm

Brainlab AG

Reason for recall

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

Action taken

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 us.support@brainlab.com.

Root cause

Software in the Use Environment

Status

Terminated

Product code

MUJ

Quantity affected

1412 systems total

Distribution

Worldwide Distribution - USA including Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Ma

Date initiated

2014-11-19

Date posted

2015-01-15

Date terminated

2018-03-28

Location

Feldkirchen, Germany

Related 510(k) clearances