GE Healthcare Recalls Muse v7 Cardiology System Due to Medication Display Error
GE Healthcare is recalling Muse v7 cardiology systems because they may display incorrect medications, potentially leading to incorrect patient treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where incorrect treatment is a potential consequence, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling the Muse v7 cardiology information system, including specific application CD models (MUSE 7.0, 7.0.2, 7.1, 7.1.1 A, and 7.1.1). The system is intended to store, access, and manage cardiovascular information for adult and pediatric patients.
The recall was initiated because the device may display incorrect medications on the screen. This error could result in incorrect treatment for patients. The recall covers 963 units distributed worldwide, including the United States (excluding Maine and the U.S. Virgin Islands) and numerous international markets.
Healthcare facilities and users should contact GE Healthcare for further instructions on how to address the software defect. No specific corrective action steps, such as software patches or device replacements, are detailed in the provided source text.
The recalled product
- 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.…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 963
Distribution
Distributed in 1 state:
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