The Recall Desk
SevereFDA (Devices)·Z-0802-2019·Announced 2019-02-13

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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.

Same manufacturer · Arjohuntleigh Magog

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