ARJOHUNTLEIGH GETINGE GROUP — Class II medical device recall Z-0802-2019
Terminated recall by Arjohuntleigh Magog, reported 2019-02-13. Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emerge
| Recall number | Z-0802-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arjohuntleigh Magog, Magog, Quebec, Canada |
| Recall initiated | 2018-12-19 |
| Classified | 2019-02-05 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2022-01-26 |
| Countries outside the US | KW, SA |
| Quantity | 231 units |
| Model numbers | 209800 |
Product
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Reason for recall
Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event.
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-0802-2019. 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.