Brainlab AG 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Brainlab AG
Lot Codes / Batch Numbers
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
Products Sold
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
Brainlab AG is recalling iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conforma due to iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WI, WY
Page updated: Jan 14, 2026