GE Healthcare Recalls Voluson Ultrasound Systems Due to Software Freeze
GE Healthcare is recalling 375 Voluson E6 and E8 ultrasound systems because an intermittent software error can cause the system to freeze.
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. The hazard is a software freeze that is intermittent and resolvable by rebooting, with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
GE Healthcare, LLC is recalling 375 units of the Voluson E6, E8, E8 Expert, and E10 Diagnostic Ultrasound Systems. The recall is due to an intermittent software issue where an "Out of Memory" error message may be displayed, causing the system to freeze. This behavior requires a specific workflow to occur and can be resolved by rebooting the system.
The affected devices were distributed worldwide, including in the United States and numerous international countries. The recall covers specific serial numbers listed in the agency's documentation. No injuries or illnesses have been reported in connection with this defect.
Healthcare providers should check their device serial numbers against the list provided by GE Healthcare. If a device is affected, the issue can be resolved by rebooting the system. Users should contact GE Healthcare for further instructions or support.
The recalled product
- Product
- GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 375
Distribution
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