GE Healthcare Recalls LOGIQ Ultrasound Systems Due to Potential Skin Burn Risk
GE Healthcare is recalling LOGIQ S8 and S7 ultrasound systems equipped with the S4-10-D probe due to a potential safety issue that may cause skin burns.
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 and involves a risk of harm (skin burn) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 2,061 units of the LOGIQ S8 and LOGIQ S7 diagnostic ultrasound systems. The recall involves specific software revisions (R1.1.1 and R1.5.1 for the S8; R1.0.1, R1.0.2, and R1.0.3 for the S7) used in conjunction with the S4-10-D Ultrasound Probe. These devices are intended for use in ultrasound evaluation.
The recall was initiated because GE Healthcare identified a potential safety issue associated with the S4-10-D Ultrasound Probe. The company noted that this issue also leads to a specification issue regarding the acoustic output of the probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultrasound Probe.
The affected units were distributed worldwide, including in the United States and numerous international countries. The source text does not specify the exact corrective action or instructions for consumers, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 2,061
Distribution
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