Z-2182-2011

KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning...

Name: Z-2182-2011 KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning...
Creator: KCI USA, Inc.
Published: 2011-02-18
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2011-02-18 / Terminated / root cause: design

FDA source

KCI USA, Inc. began a recall of KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and... on 2011-02-18. The reason FDA records is "Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user". 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-2182-2011
Status: Terminated
Initiated: 2011-02-18
Posted: 2011-05-10
Terminated: 2011-10-24
Recalling firm: KCI USA, Inc.
Product: KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.
Product code: IKZ Bed, Patient Rotation, Powered
Reason for recall: Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
Root cause tag: design
FDA root cause: Device Design
Action: Firm sent a letter with the "Warning: Improper Insertion of the RotoProne Therapy System Buckle Can Lead To Unintentional Bed Exit" to all consignees on 2/23/2011. The letter identified the affected product and the reason for the recall. Customers were instructed to read the attached product warning regarding the proper method to attach the RotoProne buckles and to post it with the device to ensure continued proper use of the buckles. If customers had questions regarding the proper use of the buckles, they were to contact KCI Customer Technical Service at 1-800-275-4524.
Quantity in commerce: 229 units
Distribution: Worldwide Distribution - USA and Kuwait.
Product codes and lots: Serial numbers: RRFK0036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRRFK00254; RRFK00256-RRFK00261; RRFK00263-RRFK00267; RRFK00269-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; and RRJK00002.

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)