FDA Device recall Z-1769-2022
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems
- FDA Device
- Class II
- ongoing
- Published 2022-09-28
On 2022-09-28 the FDA classified a Class II recall of AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems by Fresenius Medical Care Holdings, citing internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1769-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-21 |
| Published | 2022-09-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
Reason
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Identifiers
| code_info | UDI: (01)4251285200234(11)210628(21)1CHS5379 (01)4251285200234(11)160927(21)6CHS1270 (01)4251285200234(11)161109(21)6CH…UDI: (01)4251285200234(11)210628(21)1CHS5379 (01)4251285200234(11)160927(21)6CHS1270 (01)4251285200234(11)161109(21)6CHS1394 (01)4251285200234(11)161109(21)6CHS1435 (01)4251285200234(11)170131(21)7CHS1569 (01)4251285200234(11)170201(21)7CHS1583 (01)4251285200234(11)170213(21)7CHS1619 (01)4251285200234(11)170314(21)7CHS1641 (01)4251285200234(11)170519(21)7CHS1790 (01)4251285200234(11)170807(21)7CHS1953 (01)4251285200234(11)180326(21)8CHS2197 (01)4251285200234(11)181010(21)8CHS2608 (01)4251285200234(11)181102(21)8CHS2633 (01)4251285200234(11)181107(21)8CHS2644 Serial Numbers: 1CHS5379 6CHS1192 6CHS1194 6CHS1195 6CHS1196 6CHS1197 6CHS1198 6CHS1199 6CHS1200 6CHS1201 6CHS1233 6CHS1270 6CHS1394 6CHS1435 7CHS1569 7CHS1583 7CHS1619 7CHS1641 7CHS1790 7CHS1953 8CHS2197 8CHS2608 8CHS2633 8CHS2644 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1769-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.