Agency classClass IIOur severity:High FDA (Devices)·Z-1463-2022·Announced 2022-08-03

Dialysis Machine Recalled for Electrical Shock Risk in AquaC UNO H

The FDA is recalling 277 Fresenius AquaC UNO H dialysis machines due to misaligned internal ethernet cables that could expose the external port to electrical current, creating a shock risk for service technicians.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 recall of medical device presenting electrical shock risk to service technicians and authorized operators. No injuries have been reported; however, the potential hazard to qualified personnel matches the rubric criterion for High severity.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling the AquaC UNO H dialysis machine (Fresenius US-Version 24-0970-1, Vivonic Part Number G02000966-US). The recall affects 277 units distributed nationwide in the United States.

The internal ethernet cable may be misaligned, which can allow the cable's outer jacket (insulation) to become compromised due to high temperature exposure. When the insulation fails, the internal ethernet cable may conduct electrical current to the ethernet port on the outside of the device.

Service technicians and authorized operators who touch or manipulate the ethernet port face a risk of electrical shock.

Affected healthcare facilities and service technicians can refer to FDA recall notice Z-1463-2022 for the complete list of affected serial numbers and additional details.

The recalled product

Product: AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Dialysis Equipment
Hazard: electrical-shock
insulation-failure
Affected units: 277

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.

See all 2 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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