Fresenius 2008T Hemodialysis Machines Recalled for False USB Alarm
Fresenius Medical Care is recalling 2008T hemodialysis machines because they may display a false 'Remove USB Device 2' alarm when no USB device is connected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific hazard is a false alarm, which is a minor software defect rather than a direct safety risk to the patient.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 101,463 units of the Fresenius 2008T Hemodialysis Machine. The affected units include various configurations such as the 2008T Hemodialysis System with OLC/Diasafe Plus, with CDX, with BiBag, and without CDX.
The recall is due to a software issue where 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. This false alarm does not indicate an actual device connection issue.
The affected machines were distributed nationwide and in Canada, Curaca, and Guam. All serial numbers are included in this recall. Users should contact Fresenius Medical Care for instructions on how to resolve the issue.
The recalled product
- Product
- 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 WITH
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Hemodialysis
- Hazard
- Affected units
- 101,463
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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