Arjohuntleigh RotoProne Therapy System Recalled for Buckle Release Issue
Arjohuntleigh is recalling 231 RotoProne Therapy Systems because the proning arm buckle may be difficult to release, potentially delaying emergency patient access.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect could contribute to a life-threatening event, which aligns with the rubric criterion for 'significant injury' or serious harm reports.
Plain-English summary
Arjohuntleigh Magog is recalling 231 units of the RotoProne Therapy System, Model Number 209800. The recall affects all serial numbers of this specific model. The devices were distributed in the United States, Saudi Arabia, and Kuwait.
The recall was initiated because the proning arm buckle may be unable to release or may be difficult to unbuckle. This issue could delay patient access in an emergency situation, such as a cardiac arrest, which could contribute to a life-threatening event.
Healthcare facilities and consumers should contact Arjohuntleigh Magog for instructions on how to resolve the issue with the proning arm buckle.
The recalled product
- Product
- ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
- Manufacturer
- Arjohuntleigh Magog
- Affected units
- 231
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Arjohuntleigh Magog
See all →- SevereArjohuntleigh Magog Quick Connect 272 KG Scale Recall for Detachment Risk
FDA (Devices) · 2018-08-15
- HighArjohuntleigh Q-Connect Scale Recall Due to Spreader Bar Detachment Risk
FDA (Devices) · 2018-08-15
Other medical device recalls
- ModerateDRG Sperm Ab ELISA Recalled for Potential False Negative Results
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
Similar recalls
- HighArjoHuntleigh Rotoprone Therapy System Recalled for Lock Pin Malfunction
FDA (Devices) · 2014-02-12
- ModerateArjo Rotoprone Therapy System Recalled for Unapproved Medical Claims
FDA (Devices) · 2015-03-11
- HighArjoHuntleigh Recalls Chorus Mobile Patient Lifters Due to Injury Risk
FDA (Devices) · 2012-07-18
- HighArjo Disposable Repositioning Sling Recalled for Trip Hazard Risk
FDA (Devices) · 2021-09-22
- ModerateArjo RotoRest Delta Therapy System Recalled for Unapproved Medical Claims
FDA (Devices) · 2015-03-11
- HighSurgical chest support device recalled for potential cracking at attachment
FDA (Devices) · 2023-07-19