Agency classClass IIOur severity:Severe FDA (Devices)·Z-1081-2013·Announced 2013-04-17

Siemens ACUSON SC2000 Ultrasound System Recalled for Temperature Display Error

Siemens is recalling ACUSON SC2000 ultrasound systems with specific hardware due to a temperature display error that may underestimate transducer heat, posing a burn risk.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device defect that poses a risk of significant injury (esophageal burns), which aligns with the rubric criteria for a Severe (Score 4) classification involving significant injury reports or risks.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 120 units of the ACUSON SC2000 Ultrasound System, Model 10433816. The recall affects systems containing version 4 of the MPI board 10434200. These devices are used for various medical imaging applications, including cardiac, pediatric, and abdominal procedures.

The recall is due to a hardware defect where the system's display of the V5M transducer temperature may show a value lower than the actual temperature. This discrepancy occurs specifically when the system hardware contains revision 4 of the MPI Board. The inaccurate temperature reading creates a potential risk of causing esophageal burns in patients during procedures.

The affected units were distributed worldwide, including in the United States and numerous countries in Europe, Asia, the Middle East, and Australia. Healthcare facilities should identify affected units by checking the hardware version of the MPI board and contact Siemens for further instructions on corrective actions.

The recalled product

Product: Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult…
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Ultrasound System
Hazard: burn-injury
temperature-display-error
Affected units: 120

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)

All units of this model.

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Siemens Medical Solutions USA, Inc.

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