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
Reported: April 29, 2020 Initiated: March 12, 2020 #Z-1748-2020
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
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 101,463
- Distribution
- Nationwide Foreign: Canada, Curaca, Guam
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 101,463.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1748-2020.
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