Generic Name: Digital Extraoral General-purpose Dental X-ray Diagnostic System (analog Extraoral General-purpose Dental X-ray Diagnostic System) — Trade Name: Port X IV
- Recalling firm
- Name of Manufacturer and Distributor: Morita Co., Ltd. — Address of Manufacturer and Distributor: 3-33-18 Tarumi-cho, Suita City, Osaka Prefecture — License Type: Class I Medical Device...
- Product
- Lot: 製品名 ： ポートエックスIV 対象ロット： GD-905033-20623,GD-905044-20623,GD-905045-20623,GD-905051-20623 GD-905050-20623,GD-905100-20623,GD-905098-20623,GD-905099-20623 GD-905096-20623,GD-905097-20623,GD-906105-20623,GD-906106-20623 GD-906107-20623,GD-906129-20623,GD-906111-20623,GD-906116-20623 GD-906112-20623,GD-906130-20623,GD-906131-20623,GD-906124-20623 GD-906125-20623,GD-906126-20623,GD-906133-20623,GD-905034-20623 GD-906122-20623,GD-906108-20623,GD-906109-20623,GD-906110-20623 GD-906118-20623,GD-906119-20623,GD-906123-20623,GD-906121-20623...
- Reason
- Starting around August 2025, we received a frequent number of repair requests regarding oil tank leaks. Upon investigation by the manufacturer, it was determined that the cause was excessive torque (over-tightening) at the oil tank cap. We have decided to conduct a voluntary recall of 78 units from the affected lot that may have been over-tightened.
- 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/e657d472-f855-41ab-b352-8656369acb93