FDAClass IIFebruary 12, 2014

The Rotoprone therapy System is an advanced patient recall

The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy…

Why was The Rotoprone therapy System is an advanced patient recalled?

The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model #209500

Product
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy…
Recalling firm
ArjoHuntleigh Inc.
Quantity
231 units
Distribution
US Nationwide and Middle East
Recall date
February 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls