Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 104 of 120
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Reason: This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be...
Z-1806-2014 June 25, 2014 Stockholm, N/A
Ortho-Clinical Diagnostics
Class II Terminated
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chem...
Reason: Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.
Z-1741-2014 June 18, 2014 Rochester, NY
Ortho-Clinical Diagnostics
Class II Terminated
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample an...
Reason: Software anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6 , v3.2 and v3.5 Configured with Bypass Modul...
Z-1738-2014 June 18, 2014 Rochester, NY
Philips Medical Systems, Inc.
Class II Terminated
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Reason: IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
Z-1746-2014 June 18, 2014 Andover, MA
Philips Medical Systems (Cleveland) Inc
Class II Terminated
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imagin...
Reason: During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. I...
Z-1678-2014 June 11, 2014 Cleveland, OH
Spacelabs Healthcare Inc
Class II Terminated
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, a...
Reason: A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
Z-1705-2014 June 11, 2014 Snoqualmie, WA
Ortho-Clinical Diagnostics
Class II Terminated
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest...
Reason: Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possi...
Z-1677-2014 June 11, 2014 Rochester, NY
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms...
Reason: The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints
Z-1715-2014 June 11, 2014 Portage, MI
LAP of America Laser Applications, LLC
Class II Terminated
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
Reason: Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CAR...
Z-1709-2014 June 11, 2014 Boynton Beach, FL
Siemens Medical Solutions USA, Inc.
Class II Terminated
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
Reason: Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need ...
Z-1668-2014 June 4, 2014 Mountain View, CA
Siemens Medical Solutions USA, Inc.
Class II Terminated
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Reason: Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is ad...
Z-1667-2014 June 4, 2014 Mountain View, CA
Physio-Control, Inc.
Class II Terminated
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
Reason: Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low bat...
Z-1660-2014 June 4, 2014 Redmond, WA
AGFA Corp.
Class II Terminated
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic...
Reason: Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Z-1662-2014 June 4, 2014 Greenville, SC
CareFusion 303, Inc.
Class I Terminated
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under ...
Reason: CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an in...
Z-1567-2014 May 21, 2014 San Diego, CA
Baxter Corporation Englewood
Class I Terminated
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 A...
Reason: 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional ster...
Z-1566-2014 May 21, 2014 Englewood, CO
Siemens Medical Solutions USA, Inc
Class II Terminated
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quan...
Reason: Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
Z-1613-2014 May 21, 2014 Malvern, PA
GE Healthcare
Class II Terminated
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared hea...
Reason: Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to t...
Z-1551-2014 May 14, 2014 Laurel, MD
GE Healthcare
Class II Terminated
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature use...
Reason: Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to t...
Z-1548-2014 May 14, 2014 Laurel, MD
GE Healthcare
Class II Terminated
Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring fe...
Reason: Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to t...
Z-1549-2014 May 14, 2014 Laurel, MD
GE Healthcare
Class II Terminated
Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used f...
Reason: Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to t...
Z-1547-2014 May 14, 2014 Laurel, MD
INO Therapeutics (dba Ikaria)
Class II Terminated
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous mo...
Reason: An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injecto...
Z-1528-2014 May 14, 2014 Madison, WI
GE Healthcare
Class II Terminated
Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feat...
Reason: Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to t...
Z-1550-2014 May 14, 2014 Laurel, MD
Brainlab AG
Class II Terminated
ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWA...
Reason: When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, ther...
Z-1513-2014 May 7, 2014 Feldkirchen
GE Healthcare, LLC
Class II Terminated
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MR...
Reason: GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.
Z-1511-2014 May 7, 2014 Waukesha, WI
Medtronic Neuromodulation
Class II Terminated
Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and use...
Reason: Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based o...
Z-1526-2014 May 7, 2014 Minneapolis, MN