Agency classClass IIOur severity:High FDA (Devices)·Z-1425-2022·Announced 2022-07-27

Sensis diagnostic tool software may fail to display vital signs

Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.

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: FDA Class II device with risk of diagnostic failure due to software communication issue preventing vital sign display. No hospitalizations, injuries, or deaths reported, making this score 3 per the rubric.

Plain-English summary

Siemens Medical Solutions is recalling 2 units of the Sensis diagnostic tool (software version VD12A, Model 10764561) used in cardiac catheterization and interventional radiology procedures. Serial numbers 61331 and 60015 are affected.

The device may experience a communication disconnect in the ComboBox component during the first patient examination of the day or after an extended period of inactivity. When this occurs, vital signs become unavailable to the clinical team.

This device was distributed nationwide to facilities in Arizona, Florida, Kentucky, Michigan, Ohio, Puerto Rico, and Texas. Healthcare providers using affected units should contact Siemens Medical Solutions for software updates and instructions.

The recalled product

Product: Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Cardiac Diagnostic
Hazard: vital-signs-unavailable
communication-disconnect
Affected units: 2

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 (2)

UDI-DI: 04056869010137 Serial Numbers: 61331
60015

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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