Siemens ACUSON SC2000 Ultrasound System Recalled for EROA Underestimation
Siemens Medical Solutions is recalling 564 ACUSON SC2000 ultrasound systems because a specific application may underestimate the Effective Regurgitant Orifice Area (EROA) compared to other transducers.
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 harm (inaccurate diagnostic data) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 564 ACUSON SC2000 ultrasound systems. The recall involves software versions VB10A, VB10B, VB10D, and VB10E that have PRIME license 11146943 and eSie PISA license 10439823. The systems were distributed worldwide, including in the United States and numerous other countries.
The recall is due to a potential software issue where the application may underestimate the Effective Regurgitant Orifice Area (EROA) in comparison to results obtained with the 4Z1c volume transthoracic echocardiography transducer. This discrepancy could affect the accuracy of clinical measurements used for diagnosis.
Healthcare facilities should identify affected systems by checking the serial numbers listed in the official recall notice. Siemens is the recalling firm and is responsible for managing the corrective actions for these devices.
The recalled product
- Product
- ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 564
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 (3)
- Software versions VB10A
- VB10B
- VB10D
Distribution
Distributed nationwide across the United States.
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