FDA Device recall Z-0231-2026
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, P…
- FDA Device
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, P… by Ge Medical Systems, citing if a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0231-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-22 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
Reason
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
Identifiers
| code_info | UDI-DI: 00840682125499; Serial Numbers: VU221240028SA VU221250168SA VU222120101SA VU222120114SA VU222120120SA VU2224000…UDI-DI: 00840682125499; Serial Numbers: VU221240028SA VU221250168SA VU222120101SA VU222120114SA VU222120120SA VU222400056SA VU222400070SA VU222480182SA VU421010035SA VU420530073SA VU420530105SA VU420530108SA VU420530109SA VU420530110SA VU421010007SA VU421010008SA VU421010009SA VU421010010SA VU421010012SA VU421010021SA VU421010029SA VU421010040SA VU421010042SA VU422410219SA VU422410220SA VU220500166SA VU220500167SA VU222250167SA VU222250175SA VU423290038SA VU423290039SA VU423290063SA VU423290068SA VU221500205SA VU221500215SA VU221500216SA VU221500218SA VU221300012SA VU221320090SA VU221330009SA VU221330012SA VU221330013SA VU221120005SA VU221490009SA VU221490015SA VU221490031SA VU221490033SA VU221490038SA VU221490043SA VU221490113SA VU421250084SA VU420290004SA VU420290052SA VU221350037SA VU421340025SA VU421340038SA VU421340117SA VU421340120SA VU421340127SA VU421340131SA VU421340139SA VU421340142SA VU421340163SA VU421350169SA VU421350174SA VU421350179SA VU421350201SA VU421350206SA VU421350 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0231-2026%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.