Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) Recalled by GE Healthcare, LLC Due to GE Healthcare has become aware of a potential...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare, LLC directly.
Affected Products
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.
Quantity: 2061
Why Was This Recalled?
GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso
Where Was This Sold?
This product was distributed to 40 states: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA, WI, DC
About GE Healthcare, LLC
GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report