FDA Device recall Z-1992-2016
Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT…
- FDA Device
- Class II
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class II recall of Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT… by Med Tec, citing when using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1992-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-31 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Med Tec |
| Distribution | n/a |
Product
Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
Reason
When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
Identifiers
| code_info | Versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1992-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.