The Recall Desk
HighFDA (Devices)·Z-1464-2022·Announced 2022-08-03

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.
Category
Medical Device — Dialysis Equipment
Hazard
  • electrical-shock
  • equipment-defect

Distribution

Distributed nationwide across the United States.

Related recalls

Same category