Device product

AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US

Z-1770-2022

June 21, 2022

Class II

Product summary

Firm: Fresenius Medical Care Holdings, Inc.
Event: Event 90757
Status: Ongoing
Classification: Class II
Quantity: 6 units
Official record key: device-enforcement:Z-1770-2022

Official wording

Reason: Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

Code information: UDI: (01)4251285200234(11)200422(21)0CHS3987 (01)4251285200234(11)200526(21)0CHS4108 (01)4251285200234(11)210623(21)1CHS5372 (01)4251285200234(11)210707(21)1CHS5405 (01)4251285200234(11)190305(21)9CHS2881 (01)4251285200234(11)190529(21)9CHS3090 Serial Numbers: 0CHS3987 0CHS4108 1CHS5372 1CHS5405 9CHS2881 9CHS3090

Distribution pattern: US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured