Guiding clients to effective and efficient compliance and regulatory approvals

(July 13, 2020) Amy Sellers, of Tampa, FL, USA, has joined SoftwareCPR as a Regulatory Associate.  Amy recently received her J.D. from the University of Florida Levin College of Law. She has experience in regulatory pathway decisions, including analysis of intended use and product claims, as well as analysis of design changes against US regulations...
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Software CAPA
This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions. You are likely aware of the CAPA process overall and how it fits in to the quality management system for a medical device manufacturer or supplier.  Just the name itself, corrective and preventive action, describes one of the...
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Background of the Medical Software Functions Exclusion Most of those in the industry do not question whether the FDA has the authority to regulate software that qualifies as a device. However, there are many intricacies in the definitions of the 21st Century Cures Act – which, in 2016, amended the definition of medical devices in...
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Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 7/8/2020 Class II PRODUCT uCT 530 Computed Tomography X-Ray System Recall Number: Z-2472-2020 REASON Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent...
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Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 7/8/2020 Class II PRODUCT Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server) Recall Number: Z-2471-2020 REASON Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In...
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Current Status of FDA's MDDT
On June 24, 2020, there was an update to the current status of FDA’s MDDT program. CDRH announced a new tool had qualified as MDDT. This is only the sixth tool to qualify since the MDDT Guidance document was finalized in 2017. See the list of qualified tools here: https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt.   What is the Medical...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 7/8/2020 Class II PRODUCT Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only Recall Number: Z-2474-2020 REASON A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation on 6/2/2020. Voluntary:  Firm...
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Company: Ortho Clinical Diagnostics Date of Enforcement Report: 7/8/2020 Class II PRODUCT VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979 Recall Number: Z-2480-2020 REASON Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics on 7/20/2020....
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 7/8/2020 Class II PRODUCT CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 7/1/2020 Class II PRODUCT RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2 Recall Number: Z-2426-2020 REASON It is not obvious that the manual import of a treatment record into RayCare PACS does...
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Company: GE Healthcare, LLC Date of Enforcement Report: 7/1/2020 Class II PRODUCT CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro Recall Number: Z-2424-2020 REASON The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection...
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Company: Siemens Healthcare Diagnostics Inc Date of Enforcement Report: 7/1/2020 Class II PRODUCT RP500e Handheld Barcode Scanner, Zebra Model: DS4308 – HC0062BZZWW, Siemens Material Number (SMN) 11416778 Recall Number: Z-2432-2020 REASON The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes. RECALLING FIRM/MANUFACTURER Siemens Healthcare Diagnostics...
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Company: Mevion Medical Systems, Inc. Date of Enforcement Report: 7/1/2020 Class II PRODUCT MEVION S250i, MEVION S250; Proton Radiation Treatment System Recall Number: Z-2406-2020 REASON Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off. RECALLING...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 7/1/2020 Class II PRODUCT Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release – Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images,...
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Company: Suntech Medical, Inc. Date of Enforcement Report: 7/1/2020 Class II PRODUCT Oscar 2, Model 250 System Recall Number: Z-2429-2020 REASON The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. RECALLING FIRM/MANUFACTURER Suntech Medical, Inc....
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 6/17/2020 Class II PRODUCT RayStation 4.0 to RayStation 5 Service Pack 2 – Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Recall Number: Z-2339-2020 REASON Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS)...
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Company: Elekta Limited Date of Enforcement Report: 6/17/2020 Class II PRODUCT Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 Recall Number: Z-2297-2020 REASON In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images...
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Company: Philips Healthcare Informatics, Inc. Date of Enforcement Report: 6/17/2020 Class II PRODUCT IntelliSpace PACS 4.4, Product number 837507 – Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. Recall Number: Z-2338-2020 REASON Images may potentially become corrupt while using the system. RECALLING FIRM/MANUFACTURER Philips...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 6/10/2020 Class II PRODUCT ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600 Recall Number: Z-2257-2020 REASON Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or...
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Company: Hill-Rom, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Centrella Smart+ Bed, Catalog Number P7900 Recall Number: Z-2246-2020 REASON The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit. RECALLING FIRM/MANUFACTURER...
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Company: Agfa N.V. Date of Enforcement Report: 6/10/2020 Class II PRODUCT AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 – Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations,...
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Company: Insulet Corporation Date of Enforcement Report: 6/10/2020 Class II PRODUCT Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG – Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Recall Number: Z-2164-2020 REASON After the device...
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Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Xhibit Central, Model No. 96102 – Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number: Z-2261-2020 REASON The firm received...
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Company: Intuitive Surgical, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT da Vinci SP surgical system Recall Number: Z-2260-2020 REASON Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only...
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Company: Varian Medical Systems, Inc. Date of Enforcement Report: 5/13/2020 Class II PRODUCT Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 – Product Usage: is intended to assist the clinician in the delivery of external beam...
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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

Email office@softwarecpr.com
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