iPlan RT Dose is a stereotactic radiation treatment recall: Software Issue

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product

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

Recalling firm

Brainlab AG

Quantity

1,412 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.

Recall date

January 21, 2015

Classification

Class II

Status

Terminated

Agency

FDA (device)