Recall Z-1337-2019 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
| Date | Apr 18, 2019 |
| Status | Terminated |
| Reason | The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter. |
| Root cause | Process control |
| Action | The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2019 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to take the following actions: 1. Review this Medical Device Recall notice. 2. Assure that all users have received notice of this issue, and prominently display this notice where all users may access it. 3. Continue use of the device in conjunction with the backup external mechanical flowmeter found in the Terumo System 1 Accessory Kit. 4. Confirm receipt of this communication by completing and r |
| Quantity | 1258 |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172220 | Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation, Aug 17, 2017 |