Recall – Treatment planning system did not update patient in other modules

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 4/21/2021
Class II

PRODUCT

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)

Recall Number: Z-1427-2021

REASON

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

RECALLING FIRM/MANUFACTURER

RAYSEARCH LABORATORIES AB on 3/25/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1 system

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.