Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 100 of 120
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager fo...
Reason: Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the rep...
Z-0987-2015 January 21, 2015 Newark, DE
Brainlab AG
Class II Terminated
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, an...
Reason: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
Z-0956-2015 January 21, 2015 Feldkirchen
Ortho-Clinical Diagnostics
Class II Terminated
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro q...
Reason: Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibr...
Z-0968-2015 January 21, 2015 Rochester, NY
St Jude Medical Cardiac Rhythm Management Division
Class II Terminated
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Reason: Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assur...
Z-0949-2015 January 21, 2015 Sylmar, CA
Ortho-Clinical Diagnostics
Class II Terminated
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analy...
Reason: Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibr...
Z-0969-2015 January 21, 2015 Rochester, NY
Ortho-Clinical Diagnostics
Class II Terminated
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety o...
Reason: Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibr...
Z-0967-2015 January 21, 2015 Rochester, NY
Phadia US Inc
Class II Terminated
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for ...
Reason: During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a misma...
Z-0947-2015 January 21, 2015 Portage, MI
Brainlab AG
Class II Terminated
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial les...
Reason: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
Z-0957-2015 January 21, 2015 Feldkirchen
Siemens Medical Solutions USA, Inc.
Class II Terminated
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPE...
Reason: Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression re...
Z-0913-2015 January 14, 2015 Hoffman Estates, IL
McKesson Israel Ltd.
Class II Terminated
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patie...
Reason: An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.
Z-0910-2015 January 14, 2015 Tel Aviv, N/A
Siemens Medical Solutions USA, Inc.
Class II Terminated
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and or...
Reason: Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression re...
Z-0911-2015 January 14, 2015 Hoffman Estates, IL
Vision Rt Inc
Class II Terminated
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
Reason: Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
Z-0934-2015 January 14, 2015 Columbia, MD
Siemens Medical Solutions USA, Inc.
Class II Terminated
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and or...
Reason: Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression re...
Z-0912-2015 January 14, 2015 Hoffman Estates, IL
Hansen Medical Inc
Class II Terminated
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic ...
Reason: The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolle...
Z-0896-2015 January 7, 2015 Mountain View, CA
Bausch & Lomb Inc
Class II Terminated
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is use...
Reason: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Z-0864-2015 December 31, 2014 Saint Louis, MO
Illumina Inc
Class II Terminated
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripher...
Reason: It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot repor...
Z-0849-2015 December 31, 2014 San Diego, CA
Bausch & Lomb Inc
Class II Terminated
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used f...
Reason: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Z-0863-2015 December 31, 2014 Saint Louis, MO
Horiba Instruments Inc
Class II Terminated
Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical int...
Reason: HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being app...
Z-0856-2015 December 31, 2014 Irvine, CA
Ge Healthcare It
Class II Terminated
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM pr...
Reason: GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.
Z-0833-2015 December 31, 2014 Barrington, IL
Illumina Inc
Class III Terminated
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Reason: Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrumen...
Z-0850-2015 December 31, 2014 San Diego, CA
Bausch & Lomb Inc
Class II Terminated
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
Reason: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Z-0862-2015 December 31, 2014 Saint Louis, MO
Philips Ultrasound, Inc.
Class II Terminated
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analy...
Reason: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ve...
Z-0818-2015 December 24, 2014 Bothell, WA
Carestream Health Inc
Class II Terminated
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray Sy...
Reason: While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution M...
Z-0800-2015 December 24, 2014 Rochester, NY
Philips Ultrasound, Inc.
Class II Terminated
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *******************************************...
Reason: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ve...
Z-0815-2015 December 24, 2014 Bothell, WA
Philips Ultrasound, Inc.
Class II Terminated
EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and ...
Reason: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ve...
Z-0816-2015 December 24, 2014 Bothell, WA