April 15, 2020
Company: Radiometer Medical ApS Date of Enforcement Report: 4/15/2020 Class II PRODUCT ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF)....
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/15/2020 Class II PRODUCT ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 Recall Number: Z-1677-2020 REASON Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy....
Read More
Company: Change Healthcare Canada Company Date of Enforcement Report: 4/15/2020 Class II PRODUCT McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management Recall Number: Z-1682-2020 REASON Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format. RECALLING FIRM/MANUFACTURER Change Healthcare...
Read More
Company: Beckman Coulter Inc. Date of Enforcement Report: 4/15/2020 Class II PRODUCT LabPro Data Management System, UDI: 15099590676872 – Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually...
Read More

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.