Generic Name: (1) To (5) Floor-standing Digital General-purpose X-ray Diagnostic Systems; (6), (7) Ceiling-mounted X-ray Tube Holders — Trade Names: (1) Radspeed Safire Digital General Radiography System — (2) Radspeed Pro Diagnostic X-ray System — (3) Dr-xd100 Digital General Radiography System — (4) Dr-xd101 Diagnostic X-ray System — (

Recalling firm: Name of Manufacturer and Distributor: Shimadzu Corporation — Address of Manufacturer and Distributor: 1 Nishinokyo Kuwabara-cho, Nakagyo-ku, Kyoto City, Kyoto Prefecture — Type of License: Class I...
Product: Lot: (1)デジタル式Ｘ線一般撮影システム RADspeed safire 製造番号:011B715701,081C111701,081K486401,081K486501,081K486601,081K486701,081K486801,081K486901 091B806301,091B829602,091B829702,091B829802,091H746001,091K595501,101B855202,101B862003 101K885901,101K886001,101K886101,101M300203,101Q698304,40D0BE728001,40D0BE741001 40D0BED12001,40D0BF123001 出荷時期:平成19年5月〜平成26年1月出荷台数:25台 (2)診断用Ｘ線装置 RADspeed Pro 製造番号:410560113001,410560311001,410560318001,410560318002,410560321001,410560321002, 410560321003,410560334001,410560334002,410560341001,410560341002,410560351001,...
Reason: The CH-200 and CH-200M ceiling-mounted X-ray tube suspensions, which are components of the system, consist of a ceiling suspension mechanism and an X-ray tube holder (hereinafter referred to as the “holder”) for mounting the X-ray tube unit. In addition, the device features a rotation mechanism in which the X-ray tube holder shaft (hereinafter referred to as the “holder shaft”) of the ceiling suspension mechanism is fitted into the rotation bearing section of the holder so that the X-ray tube assembly can be rotated for alignment. It has been determined that, in extremely rare cases,...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/b4f19408-7994-45b2-a137-570913216c48