Generic Name: Stationary Digital Fluoroscopy System For Cardiovascular Use — Trade Names: (1) Trinias Angiography System — (2) Bransist Safire Angiography 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)血管撮影システム Trinias 製造番号：41E584962001,41F0A019A001,41F0A02AC001,41F0BF5DA001,41F0BF6E7001,41F0BF7D2001,41F0BF7D7001 41F0BF7D7002,41F0BF7D8001,41F0BF7D8002,41F0BF7D8003,41F0BF7DB001,41F0BF7E1001,41F0BF7E4001 41F0CBDD4001,41F0CBDE3001,41F0CBDEA001,41F0CBDF4001,41F0CBEE1001,41F0CBFDB001,41F0CBFE1001 41F0CBFE2001,41F0CBFE2003,41F0CBFE4001,41F0CBFE8001,41F0CD3DC001,41F0D03C7001,41F0D03CB001 41F0D03D5001,41F0D03D9001,41F0D03F3001,41F0D04CA001,41F0D04CC001,41F0D04DA001,41F0D04EB001 41F0D05D6001,41F0D05D7001,41F0D05D9001,41F0D0EC6001,41F0D35EA001,41F0D35EB001,41F0D49EC001...
- Reason
- We have discovered that, in some units of the X-ray tube holder assembly that makes up this device, the bolts securing the C-arm drive unit and other components may not have been sufficiently tightened during manufacturing. Therefore, as a voluntary corrective measure, we will inspect the tightness of these fasteners and retighten the bolts if necessary.
- 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/2eeac581-a381-4652-82d7-a20d8f505b59