Recall Z-2050-2012 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
| Date | Jul 19, 2012 (initiated Jun 18, 2012) |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst |
| Root cause | Nonconforming Material/Component |
| Action | Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 30, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers are asked to complete and return a Customer Response Form via fax to 1-800-292-6551. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall. |
| Quantity | 484 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K871131 | SARNS 9000 HEART-LUNG CONSOLE 3M Health Care, Sarns, May 21, 1987 |