Day

April 21, 2021
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...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 4/21/2021 Class II PRODUCT ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) – US, automated hematology analyzer Software Versions 6.10 and 6.11 Recall Number: Z-1386-2021 REASON Potential Sample Identification (SID) Mismatch with 14-Character Barcodes. RECALLING FIRM/MANUFACTURER Siemens Healthcare Diagnostics, Inc. on 3/5/2021. Voluntary:  Firm Initiated recall...
Read More

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.