The International Society of Pharmaceutical Engineering publishes the Good Automated Practices Guides including GAMP from 2008 which coverscomputer system validation in general and a number of more recent guides on topics ranging from mobile apps to IT infrastructure control. The current list of available guides is: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized...Read More

In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for Legacy software and clarifications to the use of risk in safety classification keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include: 1. Reduction in the...Read More

In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for legacy software and clarifications to the use of risk in safety classification, keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include: Reduction in the exemptions...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Syngo Imaging XS is a Picture Archiving and Communication System (PACS) Recall Number Z-0550-2016 REASON For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance iCT Computed Tomography X-ray system Recall Number Z-0545-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Shimadzu Medical Systems.Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Mobile X-ray system MobileDaRt Evolution/FDR Go Software Recall Number Z-0451-2016 REASON Shimadzu Corporation is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly… RECALLING FIRM/MANUFACTURER Shimadzu Medical Systems, Torrence, CA on 11/10/2015. Voluntary: Firm Initiated recall is...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance 64 Computed Tomography X-ray system Recall Number Z-0544-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance iCT SP Computed Tomography X-ray system Recall Number Z-0546-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the...Read More

Company: Draeger Medical, Inc. Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients. Recall Number Z-0436-2016 REASON The firm became aware of cases in which the battery...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity CT Computed Tomography X-ray system Recall Number Z-0549-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity Core 128 Computed Tomography X-ray system Recall Number Z-0548-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity Core Computed Tomography X-ray system Recall Number Z-0547-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: GE Medical Systems, LLC.Date of Enforcement Report 12/23/2015 Class lI: PRODUCT GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table,...Read More

Company: GE Medical Systems, LLC.Date of Enforcement Report 12/23/2015 Class lI: PRODUCT GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Brilliance 64 Computed Tomography X-ray system Recall Number Z-0407-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: Beckman Coulter Inc..Date of Enforcement Report 12/23/2015 Class lI: PRODUCT UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is...Read More

Company: Beckman Coulter Inc..Date of Enforcement Report 12/23/2015 Class lI: PRODUCT UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Ingenuity Core Computed Tomography X-ray system Recall Number Z-0406-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Cadila Healthcare Limited.Product: pharmaceutical manufacturing facilities Date: 12/23/2015 Our investigators observed specific violations during the inspection, including, but not limited to the following. Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data. a. Your firm failed to adequately control the use of computerized systems in the...Read More

Company: Beckman Coulter Inc..Date of Enforcement Report 12/23/2015 Class lI: PRODUCT UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Brilliance 64 Computed Tomography X-ray system Recall Number Z-0405-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Ingenuity CT Computed Tomography X-ray system Recall Number Z-0408-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Sun Pharmaceuticals Industries Ltd..Product: pharmaceutical manufacturing facilities Date: 12/17/2015 Our investigators observed specific violations during the inspection, including, but not limited to the following. 6. Your firm failed to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by authorized...Read More

Company:.Visicu, Inc.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an...Read More

Company:.WalkMed Infusion, LLC.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT WalkMed Infusion Triton Infusion Pump (model 300000). Packaged in a single pump box. Four pump boxes are place in an over-shipper for distribution. Recall Number Z-0369-2016 REASON WalkMed Infusion is conducting a field action on the Triton Infusion Pumps (model numbers 300000 and 400000) because...Read More

Company: Philips Medical System12/1610/28Class lI: PRODUCT Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart...Read More

Company: GE Medical Systems, LLC.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the...Read More

Company:.Carl Zeiss Meditec AG.Date of Enforcement Report 12/9/2015 Class lI: PRODUCT IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. Recall Number Z-0357-2016 REASON IOL Master software versions 7.5 and 7.7 calculation printouts and exported...Read More

Company:.Carl Zeiss Meditec AG.Date of Enforcement Report 12/9/2015 Class lI: PRODUCT IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis...Read More

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdfRead More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Syngo Imaging VB36D_HF02. Radiological image processing system. Recall Number Z-0319-2016 REASON To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. RECALLING FIRM/MANUFACTURER...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 Recall Number Z-0326-2016 REASON Ultrafiltration (UF) Volume software error inaccurate fluid removal RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 323...Read More

Company:Philips Electronics North America Corporation.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation. Recall Number Z-0320-2016 REASON The following MRx software issue has been identified: MRx model M3535A with software version F.03.06...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A Recall Number Z-0327-2016 REASON Ultrafiltration (UF) Volume software error inaccurate fluid removal RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 16...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler – Model no. NX1000-3. For home hemodialysis. Recall Number Z-0335-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler – Model no. NX1000-3-A. For home hemodialysis. Recall Number Z-0336-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4. Recall Number Z-0337-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. Recall Number Z-0325-2016 REASON When a fused series of a sagittal, coronal or radial multi station scan is generated...Read More

Company: Brainlab AG Date of Enforcement Report 11/25/2015 Class lI: PRODUCT BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery. Recall Number Z-0282-2016 REASON nstances of data sets not being accurately...Read More

Company: AGFA Healthcare Corp.Date of Enforcement Report 11/25/2015 Class lI: PRODUCT IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed. Recall Number Z-0283-2016 REASON Customers have experienced IMPAX CV...Read More

Although FDA’s Device Center tends to exempt many Mobile Medical Apps from regualtion FDA’s Drug Center has its own approach. Our current understanding is that mobile apps distributed with drugs are considered part of a combination product in many cases and the Drug Center will review the MMApp information as part of the product approval...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. Recall Number Z-0265-2016 REASON Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging. Recall Number Z-0254-2016 REASON When performing head or neck scans, the currently displayed...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device. Recall Number Z-0256-2016 REASON When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The...Read More

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm468246.htmRead More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display...Read More

Company: Innokas Medical Oy.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans Recall Number Z-0264-2016 REASON Monitor may shut down unintentionally without restarting. RECALLING FIRM/MANUFACTURER Innokas Medical Oy. Kempele, FI on 10/22/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 756 DISTRIBUTION Nationwide...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device. Recall Number Z-0258-2016 REASON When performing head or neck scans, the currently displayed SAR values could be lower...Read More