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
