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.

Class I - Dangerous

🏥 Medical Devices Recalled: November 19, 2014 Brainlab AG Other Medical Devices

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Brainlab AG
Reason for Recall:: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0956-2015

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