GE Healthcare Recalls MAC VU360 Electrocardiographs Due to Patient ID Errors
GE Healthcare is recalling 369 MAC VU360 electrocardiographs because they may display incorrect patient IDs or demographics, potentially assigning ECG reports to the wrong patient.
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 is classified as FDA Class II. The hazard involves a risk of harm (misassignment of medical records) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
GE Healthcare, LLC is recalling 369 units of the MAC VU360 Electrocardiograph (Model Number 2030360-001) worldwide. The recall was initiated due to two specific software-related issues affecting patient identification.
The first issue involves the system intermittently displaying an incorrect patient ID or visit number on the screen after scanning a patient's barcode. The second issue involves incorrect patient demographics appearing on the patient banner. Both issues may result in the electrocardiogram (ECG) report being assigned to the incorrect patient.
The source text does not specify the corrective action required or the specific steps consumers or healthcare facilities should take to resolve the issue. Users of the affected devices should refer to the official FDA recall notice for further instructions.
The recalled product
- Product
- MAC VU360, Model Number 2030360-001, Electrocardiograph
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 369
Distribution
Distribution scope not specified by the agency.
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