Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Recalled by Arjo Hospital Equipment AB Due to The recalled devices labeling and instructions for use...

Date: December 3, 2014
Company: Arjo Hospital Equipment AB
Status: Terminated
Source: FDA (Device)

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 Arjo Hospital Equipment AB directly.

Affected Products

RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.

Quantity: 271 units

Why Was This Recalled?

The recalled devices labeling and instructions for use contain unapproved medical claims.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Arjo Hospital Equipment AB

Arjo Hospital Equipment AB has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report