AquaC UNO H Dialysis Machine Recalled Due to Electrical Shock Risk
Fresenius is recalling 318 AquaC UNO H dialysis machines nationwide due to a potential electrical shock hazard affecting service technicians and operators. An internal ethernet cable may become misaligned, damaging insulation and creating an electrical hazard when the external port is touched.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall presenting an electrical shock hazard to service technicians and authorized operators. No injuries or deaths have been reported; the hazard is theoretical but significant, qualifying this as a high-severity risk-of-harm product.
Plain-English summary
Fresenius Medical Care Holdings, Inc., is recalling 318 AquaC UNO H dialysis machines distributed nationwide in the United States.
An internal ethernet cable may become misaligned, causing the cable's insulation to become compromised due to high temperature. When insulation is compromised, the internal ethernet cable could conduct electrical current to the external ethernet port on the device.
This electrical hazard poses a risk to service technicians and authorized operators who touch or manipulate the ethernet port during service or operation. Electrical shock is possible if the port is contacted.
The recalled product
- Product
- AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 318
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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