Recall Z-1957-2012 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
| Date | Jul 6, 2012 (initiated Jun 22, 2012) |
| Status | Terminated |
| Reason | Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM |
| Root cause | Device Design |
| Action | The firm, TERUMO, sent an "URGENT MEDICAL DEVICE RECALL" notice dated June 22, 2012 and addendum to the Operator's Manual via Federal Express to its customers. The letter described the product, problem and actions to be taken. The notice states to the customers "Please note that we are not recommending that you stop using your Central Control Monitor". The customers were instructed to review the Medical Device Recall notice; assure that all users are aware of this notice; place the Addendum at the beginning of the Central Control Monitor Section (page 4-1) of the Operator's Manual and complete |
| Quantity | 992 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Argentina, Belgium, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arab |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022947 | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH Terumo Cardiovascular Systems Corp., Mar 20, 2003 |