The Rotoprone therapy System is an advanced patient care system for… — Class II medical device recall Z-0926-2014
Terminated recall by ArjoHuntleigh Inc., reported 2014-02-12, distributed nationwide. The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to p
| Recall number | Z-0926-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ArjoHuntleigh Inc., San Antonio, TX, United States |
| Recall initiated | 2013-09-11 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2015-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 231 units |
| Model numbers | 209500 |
Product
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
Reason for recall
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
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-0926-2014. 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.