Generic Name: Reusable Active Endoscopic Instruments — Trade Name: Hugo Ras Instruments

Recalling firm: Name of Manufacturer/Distributor: Covidien Japan Co., Ltd. — Address of Manufacturer/Distributor: 1-2-70 Konan, Minato-ku, Tokyo — Type of License: Class I Medical Device Manufacturer/Distributor...
Product: Lot: （１）製品番号：MRASI0007 製品名称：エクストララージニードルドライバー製造番号：C21BAH0990 C21BAH0991 C21BAH0993 C21BAH0995 C21BAH0996 C21BAH1019 C21BAH1032 C21BAH1101 C21BAH1105 C21BAH1107 C21BAH1111 C21BAH1114 C21BAH1115 C21BAH1116 C21BAH1119 出荷数量：15個出荷時期：令和6年2月7日〜令和6年4月17日（２）製品番号：MRASI0011 製品名称：カディエールフォーセプス製造番号：C21BAD0574 C21BAD0575 C21BAD0576 C21BAD0577 C21BAD0578 C21BAD0579 C21BAD0580 C21BAE0930 C21BAF0433 C21BAF0434 C21BAF0435 C21BAF0436 C21BAF0439 C21BAF0440 C21BAF0441 C21BAF0737 C21BAF0738 C21BAF0739 C21BAF0740 C21BAF0741 C21BAF0742 C21BAF0743 C21BAF0745 C21BAF0746 C21BAF0747 C21BAF0748...
Reason: An investigation by the overseas manufacturer has revealed that connecting instruments with specific serial numbers to Hugo RAS systems running software version 2.2 or later may cause the message “Instrument expired. Detach instrument and replace.” to appear, rendering the instrument unusable. As a result, we have decided to conduct a voluntary recall of products with the affected serial numbers. Please note that this issue occurs when connecting the instruments subject to this voluntary recall and can be resolved by replacing them with different instruments.
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/4e8b76ff-b80e-4503-86b5-8a03142ffcf5