AquaC UNO HRecalls & reported problems
VIVONIC GmbH · The AquaC UNO H Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S) standards · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 4
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
4 FDA recall records name this device's identifier, 4 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jun 21, 2022Class IIOpen, Classified
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Z-1770-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 21, 2022Class IIOpen, Classified
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Z-1769-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 16, 2022Class IIOpen, Classified
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
Z-1464-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 16, 2022Class IIOpen, Classified
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
Z-1463-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Subsystem, Water Purification devices
- Tablo(R) Hemodialysis System PN-0003000Outset Medical, Inc. · Subsystem, Water Purification3 recalls34 deaths83 reports
- TabloCart™ with Prefiltration Drawer PN-0006813Outset Medical, Inc. · Subsystem, Water Purification1 recall0 reports
- AquaBplus AquaBplus B2 2500VIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- AquaBplus & AquaBplus B2 & AquaBplus HF 2500VIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- AquaA AquaA 900HVIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- Ultrafilter U 9000 112062Gambro Dialysatoren GmbH · Subsystem, water purification6 reports
- Millenium HX RO,MILLENIUM HX,750GPD,115~,60HZMar Cor Purification, Inc. · Subsystem, Water Purification3 reports
- CWP RO,CWP,28LPM,104HMar Cor Purification, Inc. · Subsystem, Water Purification2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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