Z-0802-2019Class II

ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

Name: Z-0802-2019 ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Creator: Arjohuntleigh Magog
Published: 2018-12-19
License: https://open.fda.gov/license/

Arjohuntleigh Magog, Inc. / initiated 2018-12-19 / Terminated / root cause: design

FDA source

Arjohuntleigh Magog began a recall of ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800 on 2018-12-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0802-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Posted: 2019-02-05
Terminated: 2022-01-26
Recalling firm: Arjohuntleigh Magog, Inc.
Product: ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Product code: IKZ Bed, Patient Rotation, Powered
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.
Root cause tag: design
FDA 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 in commerce: 231 units
Distribution: US, Saudi Arabia, and Kuwait
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0802-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0802-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-05

Product code IKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)