Protura Robotic Couch System Software — Class II medical device recall Z-1992-2016
Terminated recall by Med Tec Inc, reported 2016-06-22. When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be i
| Recall number | Z-1992-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Med Tec Inc, Orange City, IA, United States |
| Recall initiated | 2016-03-31 |
| Classified | 2016-06-15 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-02-03 |
| Countries outside the US | CH, DE |
| Quantity | 9 |
| Model numbers | MT6XSM1.6.1, MT6XSM1.7.0, MT6XSM1.7.1 |
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 for recall
When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1992-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.