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

FDA device recall Z-0611-2011 · posted 2010-12-13 · Terminated

Recall details

Recalling firm

KCI USA, Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

IKZ

Quantity affected

240 units

Distribution

Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia

Date initiated

2010-09-09

Date posted

2010-12-13

Date terminated

2011-03-21

Location

San Antonio, TX