Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its software cards for SOFTWARE 1898072 Integrated Power Console (IPC) UPGRADE v2.7.3.0.
The manufacturer is voluntarily recalling software cards for SOFTWARE 1898072 IPC UPGRADE v2.7.3.0 manufactured and distributed between 4 April 2019 and 2 March 2020 and replacement software v2.7.4.0 (CFN 1898073) should be installed on affected IPCs.
According to the manufacturer, it discovered an issue during internal testing that recently released IPC Software Upgrade v2.7.3.0 (CFN 1898072), could cause the IPC system to operate at a speed above the programmed setting value for the M5 Handpiece only IN OSCILLATE MODE. The condition was confirmed throughout the range of the M5 speed settings, being less noticeable at speeds above 4,000 rpm. There have been no complaints or adverse events reported for this issue.
The IPC Console Software Version 2.7.3.0 was released on 21 March 2019 to support the launch of the MR8 High Speed Drill used with the IPC Console. This version of software is used by field service personnel to upgrade consoles of customers that have acquired the MR8 High Speed Drill; production and service centers continue to install the current IPC Console Software (i.e. Version 2.6.2.3) on new and repaired consoles.
Affected users are advised to take the following actions:
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 May 2020