Reported Apr 21, 2021 · Ongoing

RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service…

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 · Sveavagen 9 · Stockholm, N/A · N/A

Is this the product you have?

  • RayStation Model Number
    • (9A)9.0.0.113
    • 9B (9.1.0.933)
    • 9B Service pack (9.2.0.483)
    • 10A (10.0.0.1154)
    • 10A Service pack (10.0.1.52)
    • 10B (10.1.0.613)
Lot codes and dates
  • Software version
    • 9A
    • 9B
    • 10A
    • 10B
Amount recalled
1 system

Where it was sold

  • Nationwide
  • TN

Why it was recalled

Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

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, 6:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.