The Recall Desk
ModerateFDA (Devices)·Z-0936-2019·Announced 2019-03-06

Siemens Sensis Vibe System Recalled for Software Crash Risk

Siemens Medical Solutions is recalling one Sensis Vibe System unit due to a software error that may cause system crashes during clinical procedures.

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 hazard involves a software crash that interrupts the procedure but does not report direct physical injury, death, or permanent damage, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling one unit of the Sensis Vibe System, Model Number 11007642, with software version VD10B. The recall is limited to a single unit with Serial Number 120019, which was distributed to New Jersey.

The recall is being issued because a software error may result in a system crash. If a crash occurs, the system must be restarted before the clinical procedure can be continued. In such cases, the ablation treatment must be performed with a different system or without the use of the interface.

Healthcare facilities that have this specific unit should contact Siemens Medical Solutions USA, Inc. for instructions on how to proceed. The recall is classified as Class II by the FDA.

The recalled product

Product
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Cardiology / Ablation
Hazard
Affected units
1

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)

  • Serial Number 120019

Distribution

Distributed in 1 state:

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