Recall Z-1133-2013— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-01-04, terminated 2013-07-19. It names 3 FDA 510(k) clearances: K083639, K072502, K050614. 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: GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-01-04
- Terminated
- 2013-07-19
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
3 on FDA's record- K083639 — MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
- K072502 — MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
- K050614 — MUSE CARDIOLOGY INFORMATION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.