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

FDA device recall Z-0409-2013 · posted 2012-11-20 · Terminated

Recall details

Recalling firm

KCI USA, Inc.

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

IOQ

Quantity affected

282 units

Distribution

Nationwide Distribution including AL, CA, CO, OK and GA.

Date initiated

2012-06-27

Date posted

2012-11-20

Date terminated

2013-04-22

Location

San Antonio, TX