GE Healthcare Recalls MAC VU360 Electrocardiographs for Patient Identification Errors
GE Healthcare is recalling 5,284 MAC VU360 Electrocardiographs because they may display incorrect patient identification or demographic information.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect patient identification or demographic errors, which is a significant but non-physical defect that does not explicitly report hospitalizations or structural vehicle defects.
Plain-English summary
GE Healthcare, LLC is recalling 5,284 units of the MAC VU360 Electrocardiograph (Model 2030360 001). The recall was initiated because the devices may display incorrect patient identification and/or patient demographic errors.
The affected units were distributed domestically across numerous U.S. states and territories, as well as internationally to countries including Australia, Canada, Germany, and the United Kingdom. The source text does not specify the exact number of units distributed to each location.
Healthcare facilities and consumers should contact GE Healthcare for instructions on how to address the issue. The source text does not provide specific contact details or a deadline for the recall.
The recalled product
- Product
- MAC VU360, Electrocardiograph
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Cardiology
- Hazard
- Affected units
- 5,284
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: 2030360 001
Distribution
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