Z-0957-2015Class II

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

Name: Z-0957-2015 iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal...
Creator: Brainlab AG
Published: 2014-11-19
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2014-11-19 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of... on 2014-11-19. FDA classified it as Class II and gives the reason as "iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0957-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Posted: 2015-01-15
Terminated: 2018-03-28
Recalling firm: Brainlab, Inc.
Product: iPlan RT is a 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
Root cause tag: software
FDA root cause: Software in the Use Environment
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].
Quantity in commerce: 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, 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.
Product codes and lots: Software Versions: 1) 21213 IPLAN RT DOSE 3.0 PLATFORM; 2) 21213A IPLAN RT DOSE 3.0.1 PLATFORM; 3) 21213B IPLAN RT DOSE 3.0.2 PLATFORM; 4) 21213D IPLAN RT DOSE 4.1.0 PLATFORM; 5) 21213E IPLAN RT DOSE 4.1.1 PLATFORM; 6) 21213F IPLAN RT DOSE 4.1.2 PLATFORM; 7) 21213G IPLAN RT DOSE 4.1.3 PLATFORM; 8) 21213H IPLAN RT DOSE 4.1.4 PLATFORM; 9) 21381 IPLAN RT DOSE 4.5.0 PLATFORM; 10) 21381A IPLAN RT DOSE 4.5.1 PLATFORM; 11) 21381B IPLAN RT DOSE 4.5.2 PLATFORM; 12) 21381C IPLAN RT DOSE 4.5.3 PLATFORM; 13) 21385 UPGRADE IPLAN RT DOSE 4.X TO 4.5.0; 14) 21385A UPGRADE IPLAN RT DOSE 4.X TO 4.5.1; 15) 21385B UPGRADE IPLAN RT DOSE 4.X TO 4.5.2; 16) 21385C UPGRADE IPLAN RT DOSE 4.X TO 4.5.3; 17) 21387 iPLAN RT DOSE PLATFORM 4.1 (21213); 18) 21387A iPLAN RT DOSE PLATFORM 4.1.2 (21213); 19) 21387B iPLAN RT DOSE PLATFORM 4.5.1 (21381); 20) 21387C iPLAN RT DOSE PLATFORM 4.5.2 (21381); 21) 21387D IPLAN RT DOSE PLATFORM 4.5.3(21381) V; 22) 70213 UPGRADE BRAINSCAN 5.X TO iPLAN RT DOSE 3; 23) 70213A UPGRADE BRAINSCAN 5.X TO iPLAN RT DOSE 3; 24) 70213B UPG BRAINSCAN 5.X TO iPLAN RT DOSE 3.0; 25) 70213C UPG BRAINSCAN 5.X TO iPLAN RT DOSE4.1.0; 26) 70213D UPG BRAINSCAN 5.X TO iPLAN RT DOSE 4.1.1; 27) 70213E UPG BRAINSCAN 5.X TO iPLAN RT DOSE 4.1.2; 28) 70213F UPG BRAINSCAN 5.X TO iPLAN RT DOSE 4.5.1; 29) 70214 UPGRADE BRAINSCAN 3.X/ 4.X TO IPLAN RT D; 30) 70214A UPGRADE BRAINSCAN 3.X/ 4.X TO IPLAN RT D; 31) 70214B UPG BRAINSC 3.X/4.X TO IPLAN RT DOSE 3.0; 32) 70214C UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.1.0; 33) 70214D UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.1.1; 34) 70214E UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.1.2; 35) 70214F UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.5.1; 36) 70226 UPGRADE IPLAN RT DOSE 3.0 TO 3.0.1; 37) 70226A UPGRADE IPLAN RT DOSE TO 3.0.2; 38) 70228 UPGRADE IPLAN RT DOSE 3.X TO 4.0; 39) 70228A UPG IPLAN RT DOSE 3.X TO 4.1.0; 40) 70228B UPG IPLAN RT DOSE 3.X TO 4.1.1; 41) 70228C UPG IPLAN RT DOSE 3.X TO 4.1.2; 42) 70228D UPG IPLAN RT DOSE 3.X TO 4.5.1; 43) 70228E UPG IPLAN RT DOSE 3.X TO 4.5.2; 44) 70228F UPG IPLAN RT DOSE 3.X TO 4.5.3; 45) 70235 UPGRADE BRAINSCAN TO IPLAN RT DOSE 4.5; 46) 70235A UPGRADE BRAINSCAN TO IPLAN RT DOSE 4.5.2; 47) 70235B UPGRADE BRAINSCAN TO IPLAN RT DOSE 4.5.3; 48) 70237 UPD IPLAN RT DOSE 4.x TO 4.5 (0TRANSFER); 49) 70237A UPD IPLAN RT DOSE 4.x TO 4.5.2 (O TRANS); 50) 70237B UPD IPLAN RT DOSE 4.x TO 4.5.3(O TRANS); 51) 70263 UPD IPLAN RT DOSE 4.1.x to 4.1.3.(0TRA); 52) 70440 UPD iPLAN RT DOSE 4.1.0 TO 4.1.1; 53) 70440A UPD iPLAN RT DOSE 4.1 TO 4.1.2; 54) 20146 2ND LICENCE SW - FOR ONE ADDITIONAL WS; 55) 20147 RT SRS 2ND LICENCE SW FOR ONE ADD SITE; 56) 20148 NOVALIS TX 2ND LICENCE SW ONE ADD SITE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0957-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0956-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-13
Z-0957-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-13

Product code MUJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)