FDA Device recall Z-1582-2015
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for ster…
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for ster… by Brainlab Ag, citing exacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1582-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-06 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Brainlab Ag |
| Distribution | US |
Product
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Reason
ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
Identifiers
| code_info | Software Versions: ExacTrac v. 6.x (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0); Model/Catalog Numbe…Software Versions: ExacTrac v. 6.x (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0); Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE; 48320, ET UPGRADE SOFTWARE 6.0 TO 6.1; 48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA; 49973B, ET DATA PREP / REVIEW SYSTEM; 49973A, ET DATA PREP / REVIEW SYSTEM; 49973, ET DATA PREP / REVIEW SYSTEM; 49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT; 48302, ET DATA PREP / REVIEW SYSTEM |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1582-2015%22
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