MAC VU360 Acquisition Trunk Cable and Module Holder — Class II medical device recall Z-0231-2026
Ongoing recall by GE Medical Systems, LLC, reported 2025-10-29, distributed nationwide. If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in exces
| Recall number | Z-0231-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2025-08-22 |
| Classified | 2025-10-22 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CZ, DE, DK, FI, FR, GB, HK, IE, IL, IT, JP, KR, KW, MY, NL, NO, NZ, PH, QA, SA, SE, SG, TH |
| Quantity | 29,225 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00840682125499 |
| Serial numbers | VU218440023SA, VU218440030SA, VU218450037SA, VU218450041SA, VU218450042SA, VU219170004SA, VU219180020SA, VU219180021SA, VU219230041SA, VU219230051SA, VU219230053SA, VU219230055SA, VU219230071SA, VU219230075SA, VU219240010SA, VU219250011SA, VU219250026SA, VU219250029SA, VU219270011SA, VU219270013SA, VU219270014SA, VU219280016SA, VU219280031SA, VU219280036SA, VU219290004SA and 475 more |
| Model numbers | 2030360-001 |
Product
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0231-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.