Z-0926-2014Class II

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

Name: Z-0926-2014 The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary...
Creator: ArjoHuntleigh Inc.
Published: 2013-09-11
License: https://open.fda.gov/license/

Arjohuntleigh AB / initiated 2013-09-11 / Terminated / root cause: design

FDA source

ArjoHuntleigh Inc. began a recall of The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System... on 2013-09-11. FDA classified it as Class II and gives the reason as "The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0926-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-11
Posted: 2014-02-04
Terminated: 2015-01-08
Recalling firm: Arjohuntleigh AB
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.
Product code: IKZ Bed, Patient Rotation, Powered
Reason for recall: The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Root cause tag: design
FDA root cause: Device Design
Action: ArjoHuntleigh Inc. sent a Technical Bulletin package to all affected service centers and an Urgent Field Safety Notice package to all affected customers. For rental units, a training plan was established for employees. For sold units, the notice contain a revised user manual and label explaining what to do if the lock pin becomes stuck in the "in" position. Customers that purchased the affected product were required to complete and return a Customer Response form to ArjoHuntleigh to confirm receipt and understanding of the field safety notice, and that the required actions were completed. For questions call 630-785-4885.
Quantity in commerce: 231 units
Distribution: US Nationwide and Middle East
Product codes and lots: Model #209500

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0926-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0926-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code IKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)