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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/21/2019 Class II PRODUCT SOMATOM Definition AS, Model Number 8098027 – Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician...
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Company: Fenwal Inc Date of Enforcement Report: 8/21/2019 Class II PRODUCT VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults,...
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Company: Fenwal Inc Date of Enforcement Report: 8/21/2019 Class I PRODUCT VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults,...
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The FDA has uncovered circumstances of drug quality data and information being inaccurate, which can mask problems and failures. Patients cannot be assured of the safety and effectiveness of their medication when data has been altered. One critical way to help ensure product quality is to prevent data integrity lapses from the outset. Over the...
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Company: Philips North America, LLC Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Lantis 6.1 Commander, Model # 5493072 – Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Ingenuity CT, Model # 728326, computed tomography x-ray system Recall Number: Z-2186-2019 Ingenuity Core128 Model # 728323, computed tomography x-ray system Recall Number: Z-2187-2019 Ingenuity Core Model # 728321, computed tomography x-ray system Recall Number: Z-2188-2019 iCT, Model # 728306, computed...
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Company: Ortho Clinical Diagnostics Date of Enforcement Report: 8/14/2019 Class II PRODUCT VITROS 250 Chemistry System, clinical chemistry analyzer Recall Number: Z-2174-2019 Recall Number: Z-2175-2019 VITROS 250AT Chemistry System, clinical chemistry analyzer Recall Number: Z-2176-2019 VITROS 350 Chemistry System, clinical chemistry analyzer Recall Number: Z-2177-2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ...
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Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 8/14/2019 Class II PRODUCT The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,”* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a...
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Company: Ortho Clinical Diagnostics Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT ORTHO VISION Analyzer for ID-MTS Gel Cards (ORTHO VISION), Software Version 5.12.3 and 5.12.4, Product Code: 6904577 Recall Number: B-0800-2019 ORTHO VISION Max Analyzer for ID-MTS Gel Cards (ORTHO VISION Max), Software Version 5.12.3 and 5.12.4, Product Code: 6904576 B-0801-2019 REASON Ortho...
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The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, TALON, an S&S Technology Company, located in Houston, TX, from March 11 – 28, 2019. During the inspection, an FDA investigator determined that your firm is a medical device manufacturer of various Class I & II medical equipment,...
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Company: Fresenius Kabi Date of Enforcement Report: 8/12/2019 Class I PRODUCT The Volumat MC Agilia Infusion System is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood products, into a patient’s body in controlled amounts. The pump administers fluids intravenously via an infusion tubing set and is intended...
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Tired of Cancer, a digital health startup based in the Netherlands, announced their release of a mobile app for fighting cancer related fatigue (CRF).  The Untire App is the first of its kind and aims to improve the quality of life for cancer patients and survivors. Thirty to forty percent of cancer patients suffer from...
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Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Premarket Reports (PMRs), notices, and supplements all have associated fees to be paid to the FDA before they will review a medical device product. The 2019 Medical Device User Fee Amendments (MDUFA) are listed at 2019 MDUFA. If the FDA determines that a manufacturer is a “small business”...
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Company: Philips Medical Systems Nederlands Date of Enforcement Report: 8/7/2019 Class II PRODUCT Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Recall Number: Z-1997-2019 REASON Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion’s automatic exposure control...
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Company: Elekta Inc Date of Enforcement Report: 8/7/2019 Class II PRODUCT Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System Recall Number: Z-2091-2019 REASON When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle,...
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Company: Mississippi Valley Reg Bld Ctr Date of Enforcement Report: 8/7/2019 Class II PRODUCT Red Blood Cells, Leukocytes Reduced Recall Number: B-0768-2019 Platelets Recall Number: B-0769-2019 REASON Blood products, collected during a software error with blood mixers, were distributed. RECALLING FIRM/MANUFACTURER Mississippi Valley Reg Bld Ctr on 8/7/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME...
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Some thoughts on Requirements … using the General Principles of Software Validation to help. Many times we struggle with creating software requirements and documenting them.  The FDA General Principles of Software Validation-Final Guidance helps set the FDA expectations in this area.  Section 4.1 of the guidance states: “A documented software requirements specification provides a baseline for both...
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Company: Medical Intelligence Medizintechnik Gmbh Date of Enforcement Report: 7/31/2019 Class II PRODUCT IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. Recall Number: Z-2082-2019 REASON Sometimes, although the...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 7/31/2019 Class II PRODUCT Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Recall Number: Z-2062-2019 REASON Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation...
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Company: GE Healthcare, LLC Date of Enforcement Report: 7/31/2019 Class II PRODUCT MAC VU360, Model Number 2030360-001, Electrocardiograph Recall Number: Z-2060-2019 REASON Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report...
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Company: Stanley Security Solutions Inc Date of Enforcement Report: 7/31/2019 Class II PRODUCT STANLEY Healthcare Arial 54315 Network Manager Recall Number: Z-1996-2019 REASON STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been traced back to the Arial¿ 54315 Serial-to-IP Network Gateway. RECALLING FIRM/MANUFACTURER Stanley Security Solutions Inc...
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Company: GETINGE US SALES LLC Date of Enforcement Report: 7/31/2019 Class II PRODUCT PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the...
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Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 7/31/2019 Class II PRODUCT Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. Recall Number: Z-2035-2019 REASON Several reports were received that patient records were printed with the correct patient demographics but containing another patient’s waveforms. RECALLING FIRM/MANUFACTURER Spacelabs Healthcare,...
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