Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 106 of 120
Elekta, Inc.
Class II Terminated
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Reason: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Z-1082-2014 March 12, 2014 Atlanta, GA
Elekta, Inc.
Class II Terminated
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Reason: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Z-1084-2014 March 12, 2014 Atlanta, GA
GE Healthcare, LLC
Class II Terminated
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Tran...
Reason: GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature...
Z-1147-2014 March 12, 2014 Waukesha, WI
Toshiba American Medical Systems Inc
Class II Terminated
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium...
Reason: Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly...
Z-1113-2014 March 12, 2014 Tustin, CA
GE Healthcare, LLC
Class II Terminated
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indi...
Reason: GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless ...
Z-1078-2014 March 5, 2014 Waukesha, WI
Biosense Webster, Inc.
Class II Terminated
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAY...
Reason: Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particu...
Z-1045-2014 February 26, 2014 Irwindale, CA
Sysmex America, Inc.
Class II Terminated
The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so ...
Reason: The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the soft...
Z-0949-2014 February 19, 2014 Mundelein, IL
Ortho-Clinical Diagnostics
Class II Terminated
VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-d...
Reason: Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in So...
Z-0968-2014 February 19, 2014 Rochester, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high thro...
Reason: The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
Z-0940-2014 February 19, 2014 Newark, DE
GE Healthcare, LLC
Class II Terminated
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is i...
Reason: There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient pa...
Z-0927-2014 February 12, 2014 Waukesha, WI
Siemens Medical Solutions USA, Inc
Class II Terminated
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Reason: During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo ...
Z-0907-2014 February 12, 2014 Malvern, PA
Ossur Americas, Inc.
Class II Terminated
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing produc...
Reason: OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
Z-0936-2014 February 12, 2014 Foothill Ranch, CA
Carestream Health, Inc.
Class II Terminated
KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
Reason: Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
Z-0844-2014 February 5, 2014 Rochester, NY
GE Healthcare It
Class III Terminated
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora...
Reason: GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated r...
Z-0865-2014 February 5, 2014 Barrington, IL
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 o...
Reason: When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in ...
Z-0851-2014 February 5, 2014 Newark, DE
GE Healthcare, LLC
Class II Terminated
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport with...
Reason: GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP ...
Z-0854-2014 February 5, 2014 Waukesha, WI
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automa...
Reason: Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System Ma...
Z-0823-2014 January 29, 2014 Newark, DE
GE Healthcare It
Class II Terminated
Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different...
Reason: There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selec...
Z-0748-2014 January 22, 2014 Barrington, IL
GE Healthcare, LLC
Class II Terminated
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
Reason: There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittentl...
Z-0725-2014 January 22, 2014 Waukesha, WI
Covidien
Class I Terminated
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
Reason: Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator d...
Z-0611-2014 January 15, 2014 Boulder, CO
Midmark Corp dba Progeny Inc
Class II Terminated
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnos...
Reason: An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Va...
Z-0651-2014 January 15, 2014 Lincolnshire, IL
Welch Allyn Protocol, Inc
Class II Terminated
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations f...
Reason: Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software fa...
Z-0633-2014 January 15, 2014 Beaverton, OR
GE Healthcare It
Class II Terminated
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora...
Reason: GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into fre...
Z-0620-2014 January 8, 2014 Barrington, IL
Data Innovations, Inc.
Class II Terminated
Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v...
Reason: When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005, 8.00.0001, 8.00.0002, 8...
Z-0571-2014 January 1, 2014 South Burlington, VT
EOS Imaging
Class II Terminated
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and d...
Reason: Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
Z-0580-2014 January 1, 2014 Paris France, N/A