ExacTrac 6.0.x Patient Positioning System recall
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the…
Why was ExacTrac 6.0.x Patient Positioning System recalled?
ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
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?
Affected are ExacTrac versions 6.0.0 through 6.0.5 (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5). Serial numbers/lot numbers are not applicable for a software version. Software revisions of the ExacTrac software have a specific software version number. Model/catalogue numbers: 70359-01 EXACTRAC 6.0 IR POSITIONING SOFTWARE FOC 20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE 49926 ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49926A ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49927 ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49927A ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49933 ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933A ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49934 EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49996 ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49996A ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997 ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49997A ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49928 ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928A ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R 49939A ET SOFTWARE UPDATE 6.0.X to 6.0.5 P&R 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4 49936B ET SOFTWARE UPDATE 6.0.X TO 6.0.5 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4 49938A ET SOFTWARE UPDATE 6.0.3TO 6.0.5 49973 ET DATA PREP / REVIEW SYSTEM 49973A ET DATA PREP / REVIEW SYSTEM 49973B ET DATA PREP / REVIEW SYSTEM 49998 ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49998A ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT
- Product
- ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the…
- Recalling firm
- Brainlab AG
- Quantity
- 361 systems
- Distribution
- Worldwide Distribution - USA including the states of AL, AZ, AK, CA CO, CT, FL, GA, ID, IL IN, KY, LA, MD, MA, MI, MN, NE, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and, the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Netherlands, Panama, Qatar, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
- Recall date
- September 2, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)