FDA Device recall Z-2440-2015
ExacTrac 6.0.x Patient Positioning System, Radiation therapy
- FDA Device
- Class II
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of ExacTrac 6.0.x Patient Positioning System, Radiation therapy by Brainlab Ag, citing exacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2440-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-05 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Brainlab Ag |
| Distribution | AK, AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NE, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI |
Product
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be 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 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.
Identifiers
| code_info | 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/lo…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 UP |
|---|
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-2440-2015%22
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