Siemens ACUSON P300 Ultrasound Systems Recalled for Transducer Overheating
Siemens is recalling ACUSON P300 ultrasound systems with PA230 transducers because they may exceed maximum allowable surface temperature limits.
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 the hazard involves a risk of thermal injury (burn) to patients, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 675 ACUSON P300 ultrasound systems equipped with the P300 PA 230E cardiac probe. The recall is classified as Class II by the U.S. Food and Drug Administration. The affected devices were distributed worldwide, including in the United States and numerous international markets.
The recall was initiated because the ultrasound systems, when using the PA230 transducer with a user-defined preset that includes the 100% setting for output power, could cause the transducer surface temperature to exceed the maximum allowable limit. This condition presents a risk of thermal injury to patients during use.
Healthcare facilities and users should identify affected units by checking the model number 10433816 for the ACUSON P3000 Ultrasound System and model number 10852384 for the P300 PA 320E transducer, along with the specific serial numbers listed in the official recall notice. Users should contact Siemens Medical Solutions for instructions on corrective actions.
The recalled product
- Product
- 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 675
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 (1)
- Model number 10433816 - ACUSON P3000 Ultrasound System
Distribution
Distribution scope not specified by the agency.
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