ArjoHuntleigh Rotoprone Therapy System Recalled for Lock Pin Malfunction
ArjoHuntleigh is recalling 231 Rotoprone Therapy Systems because a lock pin can become stuck, preventing patients from being positioned prone.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used for critical patients where a mechanical failure prevents essential treatment, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
ArjoHuntleigh Inc. is recalling 231 units of the Rotoprone Therapy System, model #209500. This advanced patient care system is used to treat and prevent pulmonary complications in patients with severe acute respiratory distress syndrome (ARDS) by providing prone and supine positioning.
The recall was initiated because the lock pin can become stuck in the "in" position during manual rotation. This malfunction results in the inability to prone a patient, which is a critical function of the device for improving pulmonary gas exchange in critical patients.
The affected units were distributed nationwide in the United States and in the Middle East. Consumers and healthcare facilities should contact ArjoHuntleigh Inc. for further instructions on how to address this issue.
The recalled product
- 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.…
- Manufacturer
- ArjoHuntleigh Inc.
- 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)
- Model #209500
Distribution
Distributed nationwide across the United States.
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