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.
Recall
- Recall Number
- Z-0611-2011
- Event Number
- 56849
- Firm
- KCI USA, Inc.
- FEI Number
- 1625774
- Product Code
- IKZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 9, 2010
- Posted
- December 13, 2010
- Terminated
- March 21, 2011
- Address
- 4958 Stout Dr, San Antonio, TX, 78219-4334
Description
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 complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.
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.
Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia
240 units