Z-0409-2013Class II

RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a...

Name: Z-0409-2013 RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a...
Creator: KCI USA, Inc.
Published: 2012-06-27
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2012-06-27 / Terminated / root cause: design

FDA source

KCI USA, Inc. began a recall of RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture... on 2012-06-27. FDA classified it as Class II and gives the reason as "The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the...". 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-0409-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-27
Posted: 2012-11-20
Terminated: 2013-04-22
Recalling firm: KCI USA, Inc.
Product: RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
Product code: IOQ Bed, Flotation Therapy, Powered
Reason for recall: The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
Root cause tag: design
FDA root cause: Component design/selection
Action: KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product. For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.
Quantity in commerce: 282 units
Distribution: Nationwide Distribution including AL, CA, CO, OK and GA.
Product codes and lots: Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0409-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0409-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20

Product code IOQ

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)