General Name: (1) To (5) Stationary Digital General-purpose X-ray Diagnostic Systems, — (6) To (11) Stationary Digital General-purpose X-ray Fluoroscopy Systems, — (12) To (14) Stationary Digital Cardiovascular X-ray Fluoroscopy Systems, — (15) Synchronizer For Radiation Therapy Equipment, — (16) To (22) Stationary Diagnostic X-ray Generators — Trade Name: (1) Digital General Radiography System Radspe
- 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:011B715701,0362R72807,0462R70701,0462R70702,0462R71101,071B717101,071B720301,071B720401, 081B736401,081B736501,081B736601,081C111701,081K486401,081K486501,081K486601,081K486701, 081K486801,081K486901,081K716201,081M234601,081M234701,081Q683301,081S121101,091B806301, 091B829502,091B829602,091B829702,091B829802,091H746001,091H778601,091K595501,091K899001, 101B855202,101B856203,101B862003,101H799301,101M300203,101Q698304,101R752201,40D0BE728001, 40D0BE741001,40D0BED0C001,40D0BED12001,40D0BF123001 出荷時期:平成19年3月 〜 平成26年1月 出荷台数:44台 (2)診断用X線装置 RADspeed...
- Reason
- It has been determined that if the contacts of the electromagnetic contactor (contactor) used inside the cabinet of the X-ray high-voltage unit—a component of the X-ray system described in Section 2 above—become welded together, current will continue to flow through the power supply circuit even after the unit’s power is turned off, provided that the circuit breaker on the distribution panel has not been turned off. As a result, it cannot be ruled out that the circuit may overheat and damage surrounding components. Therefore, we are providing this information to our customers and will...
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/f0b69445-d11b-4339-b771-b31f81c712b2