Recall Z-1463-2022 ยท FIP Subsystem, Water Purification
Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
| Date | Jul 25, 2022 (initiated Jun 16, 2022) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 277 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143617 | AquaC UNO H Vivonic GmbH, Oct 19, 2015 |