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Terminated

ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

FDA Recall Z-0802-2019 · Posted 2019-02-05

Recalling FirmArjohuntleigh Magog
Recall StatusTerminated
Product CodeIKZ
Date Initiated2018-12-19
Date Terminated2022-01-26
Product Quantity231 units

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.

Firm Action

Arjo hand-delivered the notice with each RotoProne Therapy System rental and delivery beginning on 12/19/2018. Arjo will require the customer to confirm the notification has been received and understood via the signed delivery notification.

Root Cause

Component design/selection

Distribution Pattern

US, Saudi Arabia, and Kuwait

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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