Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Rotoprone therapy System is an advanced patient care system Recalled by ArjoHuntleigh Inc. Due to The lock pin can become stuck in the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ArjoHuntleigh Inc. directly.
Affected Products
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.
Quantity: 231 units
Why Was This Recalled?
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ArjoHuntleigh Inc.
ArjoHuntleigh Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report