CLASS II Device recall · Reported 12 Feb 2014 · FDA Enforcement Report
The Rotoprone therapy System is an advanced patient care recalled
ArjoHuntleigh is recalling The Rotoprone therapy System is an advanced patient care system for the treatment and, distributed nationwide in the US. The recall was initiated on 11 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0926-2014
- FDA event ID
- 67248
- Recalling firm
- ArjoHuntleigh, San Antonio, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2013
- FDA classified
- 3 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 11 Sep 2013 | Recall initiated by company | |
| 3 Feb 2014 | Classified by FDA | +145 days |
| 12 Feb 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
US Nationwide and Middle East
Questions about this recall
Is The Rotoprone therapy System is an advanced patient care system for the treatment and recalled?
Yes. ArjoHuntleigh recalled The Rotoprone therapy System is an advanced patient care system for the treatment and on 11 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0926-2014.
Why was it recalled?
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Which lots are affected?
Model #209500
Where was it sold?
US Nationwide and Middle East
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other CPAP & Ventilators recalls
All 551| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
| Device | CLASS I | Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | WI |