Information Management System for Mammography Practices. Recall #Z-187-9. REASON The software was manufactured with methods that resulted in defective information being provided to the physician, and therefore, the patients with positive mammograms may not follow-up with a biopsy exam. CODE All copies of Mammoworks Version 2.6. MANUFACTURER Lumisys, Inc., (formerly Compurad), Tucson, Arizona. RECALLED BY...Read More

ACS:Centaur Automated Chemiluminescence System, used to conduct various laboratory diagnostictests. Recall #Z-363-9. REASON Software errors for V1.0 which could lead to erroneous test results. CODE All lot numbers for the ACS Centaur. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by fax dated March 25, 1998. Firm-initiated field correction complete. DISTRIBUTION Germany and Italy....Read More

3/17/98 Recon Rx neurological biofeedback monitoring1762 units Rx unit were not functioning correctly. Obsolete version 3.01 software had been installed in the units.Read More

Venturi Ventilator, used to provide a software that continouslyadapts to the patient’s changing breathing demands and assures ventilation at the lowest pressure. The display monitor provides pertient patient parameters and waveforms. Recall #Z-802-9. REASON Display monitor may go blank due to faulty inverter. CODE Serial numbers: 970192, 970190, 970154, 970164, 970169, 970172, 970138, 970161, 970163,...Read More

CIBA Corning ACS:180 SE Analyzer, used to conduct various laboratory diagnostic tests. Recall#Z-369-9. REASON Software error causes 16 different assays to not calculate SI units correctly. CODE All lot numbers for ACS 180 SE Analyzers. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by fax on November 25, 1997. Firm-initiated field correction complete. DISTRIBUTION...Read More

9/30/97 EZ-Flow 480 Ambulatory Infusion Pump 1058 devices. Defective software may cause over infusion when using the PCA mode. 1/9/98 confirmed a patient death due to a software logic error related to use in the patient controlled analgesia (PCA) mode caused the lethal dose of morphine sulfate. Two non-fatal incidents in 1996 also occurred.Read More

7/7/97 Solar 7000/8000 Patient Monitors with Software Revision 4A783 units. A software defect is causing incorrect waveform data.Read More

McGaw Stratus Ambulatory Infusion System Model 550 and Alphamed EZ Pump, Model 550 withSoftware Version 2.32.00/2.42.01. Recall #Z-188-9. REASON The pump could under infuse or blood could back up into IV lines when the pumps are running at a slow flow rate with a large infusion set. CODE Serial Numbers: P61145, P71108, P71115, P71125, P71130,...Read More

6/5/97 HP M1026a Anesthetic Gas Analyzer with O2 sensor2,284 units. The units may display innacurrate oxygen reading due to software problem.Read More

3/13/97 Sulzer Intermedics Marathon SR & DR Pacemakers 3300 units RX 5000 Software Operating System A software condition caused the parameters of the 2 pacemakers to become reversed. That is, the software cannot distinguish Marathon DR (dual chamber) from Marathon SR (single-chamber) USER PRESET values; whichever values were most recently stored will be recalled.Read More

1/10/97 Quinton Instrument Stress Test Monitors – 3 models ~7000units affected.A software anomaly could cause their treadmills to erroneously increase or decrease in speed and/or grade when the “Stop EXER” key is pressed at the end of a stage.Read More

9/27/96 Radiation Oncology Computer Systems (ROCS) Treatment Planning System Software Version 5.0.x. An error occurs when using this software version for brachytherapy dose estimations for user specified calculation points for re-oriented linear sources.Read More

CIBA Corning Acs:180 and ACS:180 Plus Analyzers, used to conduct various laboratory diagnostictests. Recall #Z-368-9. REASON Due to a software error, the ACS Folate and ACS T-Uptake assays may run without the required conditioning solution. As a result, the test results may be outside of the system requirements. CODE All serial numbers for the ACS...Read More

2/14/96 ADAC Laboratories Pinnacle Radiation Therapy Planning Software 83 tapes recalled Due to a software problem, the wedge scatter fields will be calculated incorrectly if the wedge filter is not square. Software version 2.1FRead More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:3/26/2014 Class lI: PRODUCT syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 Recall Number Z-1216-2014 REASON Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one...Read More