Z-0611-2011

RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to allow patients to...

Name: Z-0611-2011 RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to allow patients to...
Creator: KCI USA, Inc.
Published: 2010-09-09
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2010-09-09 / Terminated

FDA source

KCI USA, Inc. began a recall of RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to allow patients to be mechanically rotated to the prone position and... on 2010-09-09. The reason FDA records is "Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0611-2011
Status: Terminated
Initiated: 2010-09-09
Posted: 2010-12-13
Terminated: 2011-03-21
Recalling firm: KCI USA, Inc.
Product: RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.
Product code: IKZ Bed, Patient Rotation, Powered
Reason for recall: Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.
FDA root cause: Other
Action: KCI USA, Inc. sent an URGENT - Medical Device Safety Alert letter, dated September 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the cusotmer. Customers were instructed to have a practiced back-up plan, such as a plan for the manual proning of patients in the event that clinical circumstances dictate the need for more immediate prone therapy. For questions, customers in the US should call KCI's Technical Support Center at 1-800-275-4524, option 5. For customers outside the US they should contact their local sales representative. Customers should contact their accounts with affected product and advise them of the safety notice.
Quantity in commerce: 240 units
Distribution: Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia
Product codes and lots: Serial number ranges: RRFK00036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRFK00254; RRFK00256-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; RRJK0001; RRIK00003; RRIK00004; RRFK00234; RRFK00236; RRFK00285; RRFK00286; 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)