GE Healthcare Muse v7 cardiology information system — Class II medical device recall Z-1133-2013
Terminated recall by GE Healthcare, LLC, reported 2013-04-24, distributed in VI. GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, whic
| Recall number | Z-1133-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-01-04 |
| Classified | 2013-04-17 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-07-19 |
| Distributed | VI |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CN, CZ, DE, DK, EE, ES, FI, FR, GB, GR, IE, IL, IN, IT, JP, KR, KW, MY, NO, NZ, PH, QA, SA, SE, SG, TR, TW, ZA |
| Quantity | 963 |
| Serial numbers | B6S80105FX, SAD05473237GA, SAD06234128GA, SAE05180093GA, SBP05450003GA, SBP05450009GA, SBP05480037GA, SBP05500051GA, SBP05500067GA, SBP05520080GA, SBP05520081GA, SBP05520122GA, SBP05520136GA, SBP06080168GA, SBP06090174GA, SBP06090177GA, SBP06090183GA, SBP06100195GA, SBP06110200GA, SBP06110203GA, SBP06140216GA, SBP06140217GA, SBP06150229GA, SBP06150246GA, SBP06160260GA and 475 more |
| Model numbers | 2026443-001, 2026443-015, 2026443-017, 2026443-031, 7.1.1A |
Product
GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage cardiovascular information on adult and pediatrics patients.
Reason for recall
GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment.
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-1133-2013. 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.