AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Recall
- Recall Number
- Z-1463-2022
- Event Number
- 90527
- Firm
- Fresenius Medical Care Holdings, Inc.
- FEI Number
- 3001451489
- Product Code
- FIP
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- June 16, 2022
- Posted
- July 25, 2022
- Address
- 920 Winter St, Bld 950, Waltham, MA, 02451-1521
Description
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
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
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.
US Nationwide distribution.
277 units