Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Siemens Medical Solutions Recalled by Siemens Medical Solutions USA, Inc. Due to ACUSON P300 ultrasound systems using the PA230 transducer...
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 Siemens Medical Solutions USA, Inc. directly.
Affected Products
Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Quantity: 675
Why Was This Recalled?
ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit.
Where Was This Sold?
Class II Recall - Worldwide Distribution - US Distribution and the countries of Australia, Austria, Belgium, Bhutan, Bolivia, Botswana, Bulgaria, Canada, Chile, Colombia, Croatia, Dem. Rep. Congo, Denmark, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Ivory Coast, Japan, Kuwait, Malaysia, Mauritius, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Saudi Arabia, Serbia, Seychelles, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad,Tobago, Turkey, U.A.E. and United Kingdom.
About Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc. has 87 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report