Generic Name: Intracranial Pressure Monitor — Brand Name: Sophisa Pressio Icp Monitor

Recalling firm: Name of Manufacturer and Distributor: TKB Co., Ltd. — Address of Manufacturer and Distributor: Tokyo Front Terrace, 2-3-14 Higashi-Shinagawa, Shinagawa-ku, Tokyo — Type of License: Class I Medical...
Product: Lot: カタログ番号：PSO-4000 商品名：プレッシオ2 ICPモニタ製造番号： 17G00179 23G01816 23G01817 23G01839 23G01840 23G01841 23G01843 23G01844 23G01846 23G01847 23G01848 23G01849 23G01881 23G01882 23G01884 23G01885 23G01901 23G01902 23G02062 23G02063 23G02064 23G02065 23G02066 23G02067 23G02068 23G02069 23G02070 23G02071 23G02072 23G02074 23G02075 23G02076 23G02077 23G02078 23G02079 23G02081 23G02082 23G02083 23G02084 23G02085 23G02086 23G02087 23G02144 23G02151 23G02152 23G02153 23G02154 数量：47台出荷時期：2023年6月14日〜2024年10月9日カタログ番号：Y25-PSO-4000 商品名：プレッシオ2 ICPモニタ製造番号：23G02080 数量：1台出荷時期：2024年7月3日. Use:...
Reason: We have received reports from customers stating that when the Sophisa Pressio catheter (hereinafter referred to as the “catheter”) is connected to the Pressio 2 ICP monitor (hereinafter referred to as the “monitor”), the monitor unexpectedly reboots, preventing monitoring. An investigation by the overseas manufacturer revealed that, although the incidence rate is low, a memory (update) error occurring within the catheter when it is connected to the Monitor can cause the Monitor to reboot. We received notification from the overseas manufacturer that they would update the software so that...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/17a35a1a-5ba4-4da9-beaa-0cddb4fe4225