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Recall Observatory FDA recall evidence

Device product

RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.

Z-1281-2021

March 03, 2021

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 87471
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1281-2021

Official wording

Reason: Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

Code information: S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;

Distribution pattern: US Nationwide distribution in the state of TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later