Class II — ArjoHuntleigh Inc.
| Recalling firm | ARJOHUNTLEIGH AB |
|---|---|
| Registered facility | ARJOHUNTLEIGH AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient |
| 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 ex… |
| Quantity | 231 units |
| Distribution | US Nationwide and Middle East |
| Initiated | 2013-09-11 |
| Classified | 2014-02-03 |
| Terminated | 2015-01-08 |
| Recall number | Z-0926-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ArjoHuntleigh Inc. (Z-0926-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67248/
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