FDA Device recall Z-0234-2018
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments
- FDA Device
- Class II
- terminated
- Published 2017-12-20
On 2017-12-20 the FDA classified a Class II recall of Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments by Elekta, citing incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0234-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-01 |
| Published | 2017-12-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | US |
Product
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Reason
Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
Identifiers
| code_info | Version 1.7.3 and higher |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0234-2018%22
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