Agency classClass IIOur severity:High FDA (Devices)·Z-0683-2024·Announced 2024-01-17

Sensis Vibe Hemo Medical Device Software May Crash

Siemens is recalling 331 units of the Sensis Vibe Hemo medical device due to a potential software crash in its documentation functionality application. Units affected are distributed in California, Connecticut, and Florida.

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: This Class II medical device recall involves a software functionality risk that could affect clinical documentation access. While no injuries or actual crashes have been reported, the potential impact on medical device functionality qualifies this as a risk-of-harm product, meeting the High severity threshold per the rubric.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the Sensis Vibe Hemo medical device due to the possibility that its documentation functionality application may crash.

The recall affects 331 units of model number 11007641 with specific serial numbers. The affected units have been distributed domestically in California, Connecticut, and Florida.

If the documentation functionality crashes, users may lose access to that application functionality. No injuries or actual crashes have been reported. Users of affected devices should contact Siemens Medical Solutions USA, Inc. for additional information and guidance.

The recalled product

Product: Sensis Vibe Hemo
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device
Hazard: software-crash
documentation-loss
Affected units: 331

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 (11)

Model No. 11007641
UDI-DI 04056869010199
Serial No. 18009
106245
18016
18014
18011
18010
19001
106244
18015.

Distribution

Distributed in 3 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

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