The Recall Desk
ModerateFDA (Devices)·Z-0182-2016·Announced 2015-11-04

Siemens ACUSON SC2000 Ultrasound Systems Recalled for Hardware Defects

Siemens is recalling 2,099 ACUSON SC2000 ultrasound systems due to hardware defects involving wheel lock disconnection and system lockups.

What this means for you

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. The hazards involve mechanical disconnection and software lockups, which are operational defects without reported injuries or deaths, fitting the criteria for moderate severity.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 2,099 ACUSON SC2000 ultrasound systems, model 10433816. These imaging systems are used to measure anatomical structures and provide information for clinical diagnosis.

The recall addresses two specific hardware issues: the metal component used to engage the wheel lock may become disconnected, and the system may lock up due to misalignment between the bezel and the MPI board. The affected units were distributed worldwide, including in the United States and numerous international locations.

Siemens will provide customers with a new version of system software (VA35E or VB10C, depending on hardware configuration) and implement hardware fixes to resolve these issues in all units that have not already been corrected.

The recalled product

Product
ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
Affected units
2,099

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)

  • and 402441.

Distribution

Distributed in 1 state:

Same manufacturer · Siemens Medical Solutions USA, Inc.

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