Siemens ACUSON SC2000 Ultrasound System Recalled for Control Panel Lock Failure
Siemens is recalling 271 ACUSON SC2000 ultrasound systems because the control panel locking mechanism can fail, making the device difficult to steer during transport.
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, which typically indicates a moderate risk. The hazard involves a mechanical failure that impairs the device's transportability and control, but the source text does not report any injuries, illnesses, or fatalities.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 271 units of the ACUSON SC2000 ultrasound imaging system. The recall is due to a defect in the locking mechanism designed to hold the control panel in a fixed position. This mechanism can become loose and fail to lock the rotation of the control panel, which makes the system unable to be steered or controlled during transport.
The affected units were distributed nationwide in the United States and in numerous international locations, including Australia, Canada, Germany, Japan, and the United Kingdom. The specific model number is 10433816, and the recall covers a specific range of serial numbers listed in the official FDA record.
Consumers and healthcare facilities should check their equipment against the provided serial number list to determine if their unit is affected. If a unit is affected, Siemens is the recalling firm and should be contacted for instructions on how to resolve the issue.
The recalled product
- Product
- ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 271
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 10433816
Distribution
Distributed nationwide across the United States.
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