AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA device recall Z-1463-2022 · posted 2022-07-25 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- 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
- Action taken
- Fresenius Medical issued Urgent Medical Device Correction letter (FA-2022-16-C) on 6/16/22. Letter states reason for recall, health risk and action to take: DO NOT TOUCH THE ETHERNET PORT ON THE BACK OF THE MACHINE. " If your ethernet port cover is not covered by the enclosed cover, unplug the machine, and carefully cover it without touching the ethernet port. " Do not perform any service to the device requiring you to connect an ethernet cable to the device. Do not attempt to download FTP files via the ethernet cable. " You may continue to use the device until the device correction is made. A Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) Water Systems Service Specialist will be contacting you to schedule a correction of your portable Water Treatment system. If choosing to correct via your own Certified AquaC UNO H System Technician, you will need to contact FMCRTG prior to performing the correction. FMCRTG will provide the necessary instruction via a Change Notification. Only a Certified AquaC UNO H System Technician or FMCRTG Water Systems Service Specialist may perform this service. For questions or concerns, please contact FMCRTG Technical Support Services at 888-553-1109.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FIP
- Quantity affected
- 277 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2022-06-16
- Date posted
- 2022-07-25
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AquaC UNO H (K143617) | Vivonic GmbH | 2015-10-19 |