Recall Z-1090-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.
| Date | Jul 23, 2007 (initiated Jun 4, 2007) |
| Status | Terminated |
| Reason | Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB)) |
| Root cause | Other |
| Action | There are two separate letters dated June 4, 2007 for the customers, based on the configuration of the unit being inspected/updated in the field. These letters explains the situaiton and informs the customers that Medtronic will be visiting each customer site to inspect/update the units. Medtronic Service Technicians will complete a Field Action Certicate acknowledging the successful completion of the update. |
| Quantity | 24 units |
| Distribution | Worldwide Distribution: USA including states of PA, ND, MN, CA, AL, CO, MI, NY, AZ, and OH and countries of Sweden, Iceland, Latvia, Germany, Italy, Austria, Belgium, and France. |
| FDA record | Open on fda.gov |