Siemens ACUSON SC2000 Ultrasound System Control Panel Bolt Recall
Siemens is recalling 230 ACUSON SC2000 ultrasound systems because a bolt holding the control panel may fail, preventing the panel from locking into position.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of a control panel bolt without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 230 units of the ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The affected units have serial numbers ranging from 401100 to 401400. These systems are intended for various medical imaging applications, including cardiac, pediatric, and abdominal imaging.
The recall is due to a defect where the bolt holding the control panel in a fixed position may fail. As a result, the control panel cannot be locked into position. This issue affects the stability of the control panel during use.
The affected units were distributed worldwide, including in the United States and numerous other countries such as Australia, Canada, Germany, and Japan. Siemens is the recalling firm. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 230
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. serial numbers 401100 to 401400.
Distribution
Distribution scope not specified by the agency.
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