FDA Device recall Z-1707-2014
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery by Brainlab Ag, citing when using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1707-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-15 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Brainlab Ag |
| Distribution | US |
Product
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Reason
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
Identifiers
| code_info | ExacTrac software version 5.5.5 is included in the following model / catalog numbers: 1) 20818B ET SOFTWARE 5.5.5;…ExacTrac software version 5.5.5 is included in the following model / catalog numbers: 1) 20818B ET SOFTWARE 5.5.5; 2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5; 3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5; 4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5; 5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5; 6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5; 7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5; 8) 49660A ET INFRARED SOFTWARE 5.5.5; 9) 49961 ET DATA PREP/REVIEW SYSTEM; 10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT; 11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT; 12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT; 13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT; 14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT; 15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT |
|---|
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-1707-2014%22
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