GE Vivid Ultrasound Systems Display Incorrect Patient Names
GE Vivid ultrasound systems may display incorrect patient information due to slow DICOM response times. Seven affected units were distributed to healthcare facilities in IL, MA, NM, NY, and OK.
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: FDA Class II recall with no reported illnesses or injuries. The issue poses a risk of wrong-patient procedures through display errors, meeting the criterion for Score 3 (risk-of-harm products where injury has not yet been reported).
Plain-English summary
GE HealthCare has issued a Class II recall of certain Vivid ultrasound systems (Models E90 and E95). These systems may display incorrect patient names and demographic information on the scanner screen due to slow DICOM Worklist response times.
The affected units were distributed to healthcare facilities in Illinois, Massachusetts, New Mexico, New York, and Oklahoma. Seven units with specific serial numbers have been identified. While no illnesses or injuries have been reported, displaying wrong patient information creates a risk of procedures being performed on unintended patients.
GE HealthCare recommends that healthcare facilities verify patient information through independent means before beginning any ultrasound procedures. Facilities with affected units should contact GE HealthCare for further guidance.
The recalled product
- Product
- GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
- Manufacturer
- GE Vingmed Ultrasound As
- Affected units
- 7
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 (11)
- a) H45581LB
- UDI/DU *
- Serial Numbers: AU01170
- AU01180
- AU50159
- b) H45581D
- UDI/DI *
- Serial numbers: AU01095
- AU50476
- AU50252
- AU01002
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Vingmed Ultrasound As under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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