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ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

FDA Recall #Z-0802-2019 — Class II — December 19, 2018

Recall #Z-0802-2019 Date: December 19, 2018 Classification: Class II Status: Terminated

Product Description

ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

Reason for Recall

Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event.

Recalling Firm

Arjohuntleigh Magog — Magog, Quebec

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

231 units

Distribution

US, Saudi Arabia, and Kuwait

Code Information

All Serial Numbers

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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