FDA Device recall Z-0926-2014
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications by Arjohuntleigh, citing the lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0926-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-11 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arjohuntleigh |
| Distribution | US |
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
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Identifiers
| code_info | Model #209500 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0926-2014%22
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