Reported Nov 8, 2023 · Ongoing

RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as…

Raysearch Laboratories Ab

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: RAYSEARCH LABORATORIES AB · Eugeniavagen 18c · Stockholm, N/A · N/A

Is this the product you have?

  • RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology
  • care Product name (build number)
    • (1)RayCare 5B SP1 (5.1.1.60246)
    • (2)RayCare 5B SP3 (5.1.3.60023)
    • (3) RayCare 6A (6.0.0.60553)
Lot codes and dates
  • UDI-DI(1)RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316; (2)RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027; (3) RayCare 6A (6.0.0.60553) 0735000201056320220617
Amount recalled
2 sytems

Where it was sold

Why it was recalled

An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:39 PM UTC

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