Siemens ACUSON SC2000 Ultrasound System Recalled for Loose User Interface
Siemens Medical Solutions is recalling 843 ACUSON SC2000 ultrasound systems because the user interface assembly may become loose and fall off.
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 involves a risk-of-harm product (medical device) where a component may fall off, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 843 active units of the ACUSON SC2000 Ultrasound System. The recall is due to a defect where the user interface assembly may become loose, creating a potential for the entire module to fall off of the ultrasound system.
The affected systems are distributed worldwide, including in the United States and numerous other countries. The specific units involved are identified by Model number 10433816 and serial numbers lower than 401100. A comprehensive list of affected serial numbers is available in the official recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue. The company is the recalling firm and is responsible for managing the corrective actions for these devices.
The recalled product
- Product
- ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 843
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
Distribution
Distributed nationwide across the United States.
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