FDA Medical Device Recalls (openFDA)
Arjohuntleigh Magog: ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
- Recall number
- Z-0802-2019
- Recalling firm
- Arjohuntleigh Magog
- Product
- ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
- Status
- Terminated
- Initiated
- 2018-12-19
- Posted
- 2019-02-05
- Terminated
- 2022-01-26
- Reason
- 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.
- Root cause
- Component design/selection
- 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.
- Quantity
- 231 units
- Distribution
- US, Saudi Arabia, and Kuwait
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IKZ
- Firm FEI
- 3002655016
- Firm city
- Magog Canada
- Firm state
- Quebec
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28