Generic Name: General-purpose Dental Lighting Unit — Trade Names: (1) Lucielite Dl-702s — (2) Lucielite Dl-705s — (3) Lucielite Dl-720s
- Recalling firm
- Name of Manufacturer and Distributor: Takara Belmont Corporation, Osaka Headquarters — Address of Manufacturer and Distributor: 2-1-1 Higashi-Shinsaibashi, Chuo-ku, Osaka City, Osaka Prefecture —...
- Product
- Lot: （１）ルシエライト ＤＬ‐７０２Ｓ 製造番号：AV08C0338,AV08C0339,AV08C0340,AV08C0341,AV08C0342,AV08C0734,AV08C0735,AV08C0736,AV08C0737, AV08C0738,AV08D0708,AV08D0709,AV08D0710,AV08D0711,AV08E1000,AV08E1001,AV08E1002,AV08E1003,AV08E1004, AV08F0023,AV08F0422,AV08F0423,AV08F0424,AV08F0425,AV08F0426,AV08H0115,AV08H0263,AV08H0264,AV08H0265, AV08H0266,AV08H0267,AV08I0557,AV08I0558,AV08I0560,AV08I0561,AV08I0800,AV08I0801,AV08I0986,AV08I0988, AV08I0990,AV08J0323,AV08J0324,AV08J0326,AV08K0222,AV08K0224,AV08K0225,AV08K0411,AV08K0412,AV08K0413,...
- Reason
- We have received reports that the mirror cover on this product fell off and struck a patient, causing minor burns. While the cover will not fall off if it is securely locked in place, there is a possibility it could fall if the lock status is not properly verified; therefore, we are conducting a voluntary recall to install a wire to prevent it from falling.
- 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/b0119d2b-6a97-4d64-b3b9-b79184efdb19