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Software in Medical Devices – Update for Q1 & Q2 2016  This is a continuation of the software updates I have been sending out.  Please check out all of the references to download and/or to purchase. Software Recalls Q1 and Q2/2016 We have been following the recalls and there were a growing number of recalls that are listed where software played a role in the recall. The following are additional examples of recalls involving software directly as listed on the FDA website. There were almost 60 recalls in this quarter relating to software, including 3 class I recalls. There may…

Software in Medical Devices – Update January 31, 2016 This is a continuation of the software updates I have been sending out.  Please check out all of the references to download and/or to purchase. Software Recalls Q2, Q3 and Q4/2015 We have been following the recalls and there were a growing number of recalls that are listed where software played a role in the recall. The following are additional examples of recalls involving software directly. There were over 150 recalls in these quarters relating to software, including 5 class I recalls. Brainlab Cranial Image-Guided Surgery (IGS) System, Class I -…

Software in Medical Devices – Update This is a continuation of the software updates I have been sending out.  Please check out all of the references to download and/or to purchase. Software Recalls Q1/2015 We have been following the recalls and there were a growing number of recalls that are listed where software played a role in the recall. The following are additional examples of recalls involving software directly: Hospira Plum A+,Plum A+3 Infusion Systems, Class I - The infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound…

Software in Medical Devices – Update This is a continuation of the software updates I have been sending out. Please check out all of the references to download and/or to purchase. Software Recalls 2014/2015 Last update we noted the FDA report and recalls for the end of 2014/beginning of 2015. We have been following the recalls and there were a growing number of recalls that are listed where software played a role in the recall. The following are additional examples of recalls involving software directly: Covidien Puritan Bennett 980 Ventilator, Class I - A software issue may lead to ventilator…

Software in Medical Devices – Update This is a continuation of the software updates I have been sending out. Please check out all of the references to download and/or to purchase. Software Recalls 2014 Last update we noted the FDA report and recalls for the beginning of 2014. We have been following the recalls for 2014 and there were a number of recalls that are listed for 2014 where software played a role in the recall. The following are additional examples of recalls for 2014 involving software directly: ICU Medical, ConMed Stat2 Flow Controller – Delivers Higher Flow Rate than…

Software in Medical Devices - Update This is a continuation of the software updates I have been sending out. Software Recalls 2014 Last update we noted the FDA report and recalls for 2013. We have been following the recalls for 2014 and there were a number of recalls that are listed for 2014 where software played a role in the recall. The following are few examples of recalls for 2014 involving software directly: Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System with Version 2.0 Software – software defect causes the system to stop working. Baxter Healthcare Corporation, Sigma Spectrum Infusion Pumps…

Software in Medical Devices - Update We have previously written about various aspects of the software life cycle development process, especially, the verification and validation activities. We would like to present you with an update on what is happening in the regulatory arena and how the regulatory groups are checking up on what we are doing.  We will try to keep you informed every so often, but please remember that the standards development process is a very long process and they don’t change Software Recalls 2013 The estimate for software recalls by the FDA for 2013 is 197. The software…

Software in Medical Devices - Update  We have previously written about various aspects of the software development process, especially, the verification and validation activities. We would like to present you with an update on what is happening in the regulatory arena and how the regulatory groups are checking up on what we are doing. Software Recalls 2012 The estimate for software recalls by the FDA for 2012 is 173. The software recalls for 2011 were 177 and for 2010 were 76. So far there are quite a few software recalls in 2013. New Standards/Guidances There are a number of new…