Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 94 of 120
Philips Electronics North America Corporation
Class II Terminated
Philips Healthcare Ingenuity Core Computed Tomography X-ray system
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.
Z-0406-2016 December 23, 2015 Andover, MA
bioMerieux, Inc.
Class II Terminated
MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application a...
Reason: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same speci...
Z-0430-2016 December 23, 2015 Durham, NC
bioMerieux, Inc.
Class II Terminated
MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the L...
Reason: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same speci...
Z-0427-2016 December 23, 2015 Durham, NC
Philips Electronics North America Corporation
Class II Terminated
Philips Healthcare Ingenuity CT Computed Tomography X-ray system
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.
Z-0408-2016 December 23, 2015 Andover, MA
bioMerieux, Inc.
Class II Terminated
MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the L...
Reason: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same speci...
Z-0425-2016 December 23, 2015 Durham, NC
Beckman Coulter Inc.
Class II Terminated
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole...
Reason: Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creati...
Z-0434-2016 December 23, 2015 Brea, CA
bioMerieux, Inc.
Class II Terminated
MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS...
Reason: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same speci...
Z-0429-2016 December 23, 2015 Durham, NC
bioMerieux, Inc.
Class II Terminated
MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS...
Reason: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same speci...
Z-0428-2016 December 23, 2015 Durham, NC
Beckman Coulter Inc.
Class II Terminated
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...
Reason: Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creati...
Z-0432-2016 December 23, 2015 Brea, CA
Beckman Coulter Inc.
Class II Terminated
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 i...
Reason: Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creati...
Z-0433-2016 December 23, 2015 Brea, CA
bioMerieux, Inc.
Class II Terminated
MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application a...
Reason: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same speci...
Z-0431-2016 December 23, 2015 Durham, NC
Philips Electronics North America Corporation
Class II Terminated
Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
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.
Z-0407-2016 December 23, 2015 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Philips Healthcare Brilliance 64 Computed Tomography X-ray system
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.
Z-0405-2016 December 23, 2015 Andover, MA
Visicu, Inc.
Class II Terminated
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 di...
Reason: A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen functi...
Z-0399-2016 December 16, 2015 Baltimore, MD
Philips Medical Systems (Cleveland) Inc
Class II Terminated
Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dat...
Reason: Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, i...
Z-0409-2016 December 16, 2015 Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class II Terminated
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visu...
Reason: Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locat...
Z-0400-2016 December 16, 2015 Cleveland, OH
Philips Medical Systems, Inc.
Class II Terminated
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 intend...
Reason: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
Z-0374-2016 December 16, 2015 Andover, MA
Carl Zeiss Meditec AG
Class II Terminated
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 implantati...
Reason: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Z-0357-2016 December 9, 2015 Jena
Carl Zeiss Meditec AG
Class II Terminated
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, whi...
Reason: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Z-0358-2016 December 9, 2015 Jena
NxStage Medical, Inc.
Class II Terminated
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
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
Z-0335-2016 December 2, 2015 Lawrence, MA
NxStage Medical, Inc.
Class II Terminated
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
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
Z-0336-2016 December 2, 2015 Lawrence, MA
Philips Electronics North America Corporation
Class II Terminated
Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fib...
Reason: The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the aut...
Z-0320-2016 December 2, 2015 Andover, MA
NxStage Medical, Inc.
Class II Terminated
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
Reason: Ultrafiltration (UF) Volume software error inaccurate fluid removal
Z-0327-2016 December 2, 2015 Lawrence, MA
Philips Medical Systems, Inc.
Class II Terminated
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.
Reason: When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R...
Z-0325-2016 December 2, 2015 Andover, MA
NxStage Medical, Inc.
Class II Terminated
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
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
Z-0337-2016 December 2, 2015 Lawrence, MA