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Recall Observatory FDA recall evidence

Device product

Sensis Vibe Hemo

Z-0683-2024

November 29, 2023

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 93637
Status
Ongoing
Classification
Class II
Quantity
331 units
Official record key
device-enforcement:Z-0683-2024

Official wording

Reason: The possibility of the Sensis documentation functionality application to crash.

Code information: Model No. 11007641; UDI-DI 04056869010199; Serial No. 18009, 106245, 18016, 18014, 18011, 18010, 19001, 106244, 18015.

Distribution pattern: Domestic: CA, CT, & FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The possibility of the Sensis documentation functionality application to crash.