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Puget Sound Blood Center and ProgramProduct: blood and blood products Date: 3/16/2013 During the inspection, FDA investigators documented significant deviations from applicable current Good Manufacturing Practice (cGMP) regulations for blood and blood products, Title 21, Code of Federal Regulations (21 CFR), Parts 606, 610 and 640 and the cGMP regulations for finished pharmaceuticals, 21 CFR...
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Company:Steris Corporation Date of Enforcement Report 3/13/2013 Class ll: PRODUCT AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. Recall Number Z-0915-2013 REASON The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during...
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Company:Beckman Coulter Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. Recall Number Z-0913-2013 REASON Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration...
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Company:GE Healthcare, LLC Date of Enforcement Report 3/13/2013 Class ll: PRODUCT GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with...
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Company:Philips Healthcare Inc Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Philips Digital Diagnost Stationary radiographic system. Recall Number Z-0900-2013 REASON When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the...
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Company:Philips Medical Systems Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken...
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Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY. Recall Number Z-0907-2013 REASON Siemens...
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Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System. Recall Number Z-0881-2013 REASON Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to...
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Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, GEMINI LXL – Model #882412; GEMINI TF 16 – Model #882470 and Model #882473; GEMINI TF 64 – Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that...
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Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Ingenuity TF PET/CT Diagnostic imaging system Recall Number Z-0897-2013 REASON Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients. RECALLING FIRM/MANUFACTURER Philips...
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Company:Intel-GE Care Innovations LLC. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents’ movements. Recall Number Z-0877-2013 REASON Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect...
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Company:GE Healthcare, LLC Date of Enforcement Report 3/6/2013 Class ll: PRODUCT GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System Recall Number Z-0761-2013 REASON GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code...
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Company:GE Healthcare, LLC Date of Enforcement Report 3/6/2013 Class ll: PRODUCT GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts. Recall Number Z-0703-2013 and Z-0704-2013 REASON It was discovered GE Healthcare...
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Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244. Recall Number Z-0880-2013 REASON Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray...
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Company:Philips Healthcare Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system Recall Number Z-0884-2013 REASON When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset...
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Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall Number...
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Company:Elekta, Inc. Date of Enforcement Report 2/27/2013 Class ll: PRODUCT Monaco RTP System. Radiation treatment planning. Recall Number Z-0841-2013 REASON The beam is displayed at the “gantry” angle, but the dose is calculated at the “rotation_start” angle. RECALLING FIRM/MANUFACTURER Elekta, Inc., Atlanta, GA,I on 2/11/2013. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company:Varian Medical Systems, Inc. Oncology Systems Date of Enforcement Report 2/27/2013 Class ll: PRODUCT Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Recall Number Z-0867-2013 REASON Varian has identified an anomaly with the Eclipse...
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Company:GE Healthcare, LLC Date of Enforcement Report 2/20/2013 Class ll: PRODUCT GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. Recall Number Z-0813-2013 REASON GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on...
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Company:Mindray DS USA, Inc. d.b.a. Mindray North America Date of Enforcement Report 2/20/2013 Class ll: PRODUCT Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and...
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Company:Terumo Cardiovascular Systems Corporation Date of Enforcement Report 2/20/2013 Class ll: PRODUCT Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels. Recall Number Z-0802-2013 REASON Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size...
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Company:Blood Bank Computer Systems, Inc Date of Enforcement Report 2/13/2013 Class ll: PRODUCT Blood Bank Control System (BBCS) Primary Application 5.0 – software for device. Recall Number B-0726-13 REASON Blood Bank software, with a defect or glitch, was distributed.. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc Auburn, WA on 10/18/2011. Voluntary: Firm Initiated recall is...
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Company:Dept Of Veterans Affairs Office Of Information & Technology Date of Enforcement Report 2/13/2013 Class ll: PRODUCT VistA Blood Establishment Computer Software (VBECS) Recall Number B-0673-13 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Dept Of Veterans Affairs Office Of Information & Technology, Hines, IL on 11/2/2012. Voluntary: Firm Initiated recall is...
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Company:Envoy Medical Corp Date of Enforcement Report 2/6/2013 Class ll: PRODUCT Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. Part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer. Recall Number Z-0750-2013 REASON Envoy Medical is conducting a voluntary correction...
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Company:GE Healthcare, LLC. Date of Enforcement Report 2/6/2013 Class ll: PRODUCT AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. Recall Number Z-0754-2013 REASON It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image...
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Company:Hamilton Medical Inc. Date of Enforcement Report 2/6/2013 Class l: PRODUCT HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Recall Number Z-0741-2013 REASON Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high...
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Company:Roche Molecular Systems, Inc. Date of Enforcement Report 2/6/2013 Class ll: PRODUCT COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. Recall Number Z-0762-2013 REASON The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test...
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Company:Becton Dickinson & Co. Date of Enforcement Report 1/30/2013 Class ll: PRODUCT BD MAX ™ (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA*** The BD MAX” System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification...
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Company:Roche Diagnostics Operations, Inc. . Date of Enforcement Report 1/30/2013 Class ll: PRODUCT Roche COBAS INTEGRA 400 and 400 plus Analyzer The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. Recall Number Z-0696-2013 REASON A software...
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The total number of FDA software, computer system, and electronic records warning letters in 2012 is approximately 30 which is up from 18 in 2011 and fewer in 2009 and 2010. This is based on the keyword searches we perform on a regular basis but is not guaranteed to be comprehensive.
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A workshop with approximately 80 invited medical wireless experts was held in October 2012. This report, at the link provided, documents the discussion and outcomes of this workshop. A follow-up meeting is planned for March 2013. 2012_Wireless_Workshop_Publication
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Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/23/2013 Class ll: PRODUCT Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 – Model #728231; and Ingenuity CT – Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended...
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Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/23/2013 Class ll: PRODUCT Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer...
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Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/23/2013 Class ll: PRODUCT Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an...
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Company: Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 1/16/2013 Class ll: PRODUCT ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Recall Number Z-0645-2013 REASON Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect...
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Company: Abbott Molecular Date of Enforcement Report 1/9/2013 Class ll: PRODUCT Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL...
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Company: Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 1/9/2013 Class ll: PRODUCT ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. Recall Number Z-0632-2013 REASON Horiba Medical is...
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Company: Mindray DS USA Date of Enforcement Report 1/9/2013 Class ll: PRODUCT DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network...
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Company: Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 1/9/2013 Class ll: PRODUCT PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and urine....
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This is one of the first mobile medical app recallsl we have seen posted. It is for an app that was only intended to be released in Brazil but was published on the iPhone store and available in the U.S. Its intended use is diabetes education. The full recall excerpt is available on our Recalls...
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http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM319824.pdf
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Company: Roche Molecular Systems, Inc. Date of Enforcement Report 1/2/2013 Class ll: PRODUCT COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland. Recall Number Z-0614-2013 REASON Certain COBAS AmpliPrep instruments...
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Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/2/2013 Class ll: PRODUCT Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by...
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Company: sanofi-aventis US, Inc.. Date of Enforcement Report 1/2/2013 Class ll: PRODUCT Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes. Recall Number Z-0609-2013 REASON Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as...
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AAMI and FDA held a two day event Oct 2-3, 2012, as a summit on interoperability. 260 people attended. AAMI has authorized widespread distribution of the proceedings document from this event (see the link provided). Interoperability Summit 2012
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