Generic Name: Stationary Digital Fluoroscopy System For Cardiovascular Applications — Trade Name: Azurion Angiography X-ray System

Recalling firm: Name of Manufacturer/Distributor: Philips Japan, Ltd. — Address of Manufacturer/Distributor: Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo — License Type: Class I Medical Device...
Product: Lot: 血管造影X線診断装置 Azurion 製品コード：722063 製造番号：113 製品コード：722064 製造番号：37, 72, 108, 245 製品コード：722067 製造番号：21, 27, 28, 31, 37, 38, 39, 40, 44, 49, 50, 51, 56, 61, 63, 72, 73, 78, 79, 80, 84, 85, 86, 87, 88, 89, 90, 91, 93, 94, 96, 99, 102, 110, 117, 118, 119, 120, 121, 129, 130, 137, 139, 145, 159, 161, 167, 170, 171, 175, 178, 179, 183, 185, 186, 189, 193, 194, 195, 196, 197, 198, 199, 200, 227, 229, 239, 245, 252 製品コード：722068 製造番号：45, 61, 63, 66, 67, 90, 98, 100, 105, 106, 108, 112, 116, 132, 135, 139, 144, 152, 154, 155, 156, 157, 161, 163, 175, 183, 186, 187, 188, 189, 191, 197, 200, 201,...
Reason: The overseas manufacturer has identified a software issue in system software versions R1 and R2 of this device related to communication between the system software and the X-ray generator firmware. This issue may, in rare cases, render the X-ray inoperable due to pedal taps or phase errors. The issue can be resolved by restarting the system. Therefore, as we have been notified by the overseas manufacturer that a software update will be performed for system software version R2, we will carry out this procedure domestically as a voluntary corrective action. Additionally, for devices running...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/a4ab6df0-d013-4e54-a299-eb7cea520d6a