Z-1748-2020 Class II Ongoing
FDA device recall Z-1748-2020 was initiated by Fresenius Medical Care Holdings, Inc. on March 12, 2020 and is designated Class II. Reason for recall: A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine The recall status is ongoing. Affected quantity: 101,463.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- March 12, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 101,463
Product Description
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN
Reason for Recall
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
Distribution Pattern
Nationwide Foreign: Canada, Curaca, Guam
Code Information
All serial numbers