Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300

As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.

The firm notified the Japanese consignees by letter on 12/12/2021. The letter stated the following: "In our company's records, the software version of your hospital's integrated power console (IPC) is not v2.7.3.0. However, we found that there were cases in other facilities that the software version was updated to v2.7.3.0 was not recorded in our company's records even though the software version was updated to v2.7.3.0.. Therefore, we proceed the following measures. Thank you for your understanding and cooperation. Content l If it has been confirmed that the software used in your hospital is v2.7.3.0, please contact your Medtronic representative or distributor representative and suspend to use with the M5 handpiece (the method of checking the software version is described in the separate sheet). l Medtronic representative or distributor representative contact and visit to check the software version of your hospital's IPC."