Z-2350-2021 Class II Terminated
FDA device recall Z-2350-2021 was initiated by Terumo Cardiovascular Systems Corporation on June 8, 2021 and is designated Class II. Reason for recall: intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monit… The recall status is terminated (terminated June 28, 2022). Affected quantity: 1 unit OUS.
Recall Details
- Product Type
- Devices
- Report Date
- September 1, 2021
- Initiation Date
- June 8, 2021
- Termination Date
- June 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit OUS
Product Description
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Reason for Recall
intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs
Distribution Pattern
International distribution in the country of Panama.
Code Information
S/N: 01751 UDI: 00886799000588