Generic Name: Ceiling Mounted X-ray Tube Supporter Trade Name: (1)x-ray Tube Holder Sx-a300 (2)x-ray Tube Holder Sx-a200 (3)x-ray Tube Holder Sx-a8
- Recalling firm
- Location: 798 Miyadai, Kaisei-cho, Ashigarakami-gun, Kanagawa Prefecture Type of License: Type 1 medical device manufacturing and sales License Number: 14B1X10022
- Product
- Lot: (1)X線管保持装置 SX-A300 7C00000125 7C00000225 7C00000825 7C00000925 7C00001025 7C00006625 7C00006725 7C00006925 7C00007025 7C00008525 7C00008625 7C00008725 7C00008825 7C00008925 7C00009025 7C00009125 7C00009225 7C00010025 7C00016525 7C00016625 7C00016725 7C00016825 7C00016925 7C00017025 7C00017125 7C00017225 7C00023225 7C00035325 7C00035425 7C00035525 7C00035625 7C00035825 7C00035925 7C00042625 7C00042725 7C00042825 7C00052725 7C00052825 7C00052924 7C00052925 7C00053024 7C00053025 7C00053125 7C00053225 7C00067225 7C00067325 7C00067425 7C00067525 7C00067625 7C00071725 7C00075724 7C00075824...
- Reason
- In one case, a part of the ceiling rail fixing point came off, causing the ceiling rail and the main unit of the device to fall. As a result of the investigation, it was found that there was a deficiency in the installation work of the ceiling rail. Therefore, the company will conduct a voluntary repair to ensure that the installation work, including the ceiling rail installation, is appropriate. If any deficiencies are found as a result of the inspection, necessary corrective actions will be taken.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Recall date
- 2026-03-03
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/0e5c67bb-0180-4c9f-82c0-514afde21bd3