Hemodialysis Water Purification Unit Recalled for Missing EMI Shielding
Fresenius is recalling 24 units of the AquaC UNO H reverse osmosis unit because internal ethernet cables lack ferrite cores, compromising electromagnetic compatibility in hemodialysis water purification systems.
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: This is an FDA Class II medical device recall with a potential electromagnetic compatibility hazard affecting a critical hemodialysis water purification component. Per the rubric, it qualifies as a risk-of-harm product where no illness or injury has been reported in the source text.
Plain-English summary
Fresenius Medical Care is recalling the AquaC UNO H reverse osmosis water purification unit (Fresenius Part Number 24-10VA-1, Vivonic Part Number G02000970-US) intended for use with hemodialysis systems. This recall affects 24 units distributed across the United States.
The recall was initiated because the internal ethernet cables in the affected units are missing one or both ferrite cores. Ferrite cores are critical for ensuring electromagnetic compatibility of the device. Without them, the device's protection against electromagnetic interference is compromised.
Affected units have been identified in Arizona, California, Washington D.C., Florida, Georgia, Indiana, Massachusetts, Nevada, New York, Pennsylvania, and Texas. Healthcare facilities and dialysis centers should verify whether they have received any of the recalled units by checking the provided serial numbers and UDI codes against their equipment inventory.
The recalled product
- Product
- AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- electromagnetic-interference
Distribution
Distributed nationwide across the United States.
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