Generic Name: (1) Digital Extraoral General-purpose Dental X-ray Diagnostic System (analog Extraoral General-purpose Dental X-ray Diagnostic System) (2) Analog — Extraoral General-purpose Dental X-ray Diagnostic System — Trade Name: (1) Port X IV — (2) Port X Ive
- Recalling firm
- Name of Manufacturer and Distributor: Morita Co., Ltd. — Address of Manufacturer and Distributor: 3-33-18 Tarumi-cho, Suita City, Osaka Prefecture — Type of License: Class I Medical Device...
- Product
- Lot: 販売名 ：(1)ポートエックスIV 対象ロット： GD-526016-20625,GD-526020-20625,GD-526022-20625,GD-526004-20625 GD-526001-20625,GD-507001-20625,GD-526002-20625,GD-526007-20625 GD-526018-20625,GD-526030-20625,GD-526028-20625,GD-526003-20625 GD-526021-20625,GD-526017-20625,GD-526019-20625,GD-526029-20625 GD-526032-20625,GD-526011-20625,GD-526012-20625,GD-526013-20625 GD-526015-20625,GD-526031-20625 数量及び出荷時期： 22台 令和7年7月14日 〜 令和7年9月8日 販売名 ：(2)ポートエックスIVe 対象ロット： GD-602023-20625,GD-602024-20625,GD-328001-20625,GD-328003-20625 GD-328008-20625,GD-328002-20625,GD-407002-20625,GD-602026-20625...
- Reason
- We have received reports from the market that batteries are unable to charge. Following an investigation by the manufacturer, it was determined that in this particular lot, if the power source is connected after the battery has naturally discharged, a short circuit may occur within the charging circuit board, preventing the battery from charging. Furthermore, since the short circuit may cause minor sparks and smoke, we have decided to conduct a recall.
- 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/f3d2520d-0b83-412a-843e-8553ad194baf