Generic Name: Oxygen Concentrator — Trade Name: Clean Sanso Fh-100/5l
Clean Sanso FH-100/5L Oxygen Concentrator Recall Summary Clean Sanso FH-100/5L oxygen concentrators with specific serial numbers are being recalled because a faulty automated inspection system failed to properly record oxygen concentration readings during manufacturing, allowing some units to be shipped without complete quality checks. Testing has confirmed the devices are delivering oxygen at the correct concentration, and no health problems have been reported so far. This recall affects numerous units produced by Fukuda Electronics Co., Ltd.
- Recalling firm
- Name of Manufacturer/Distributor: Fukuda Electronics Co., Ltd. — Address of Manufacturer/Distributor: 3-39-4 Hongo, Bunkyo-ku, Tokyo — Type of License: Class I Medical Device...
- Product
- Lot: 型式 ：FH-100／5L 製造番号：ZBB00042,ZBB00053,ZBC00091,ZBC00097,ZBC00124,ZBC00160,50038772,50040038,50041090,50041566, 50042139,50042519,50043074,50043173,50044126,50044413,50045125,50045502,50045805,50045851, 50046015,50046123,50046267,50046317,50046424,50046507,50047112,50047226,50047648,50047690, 50047938,50047975,50048115,50048218,50048238,50048415,50048615,50049060,50049309,50049364, 50049382,50049392,50049436,50049492,50049523,50049693,50049729,50049893,50049982,50050006, 50050079,50050118,50050144,50050215,50050226,50050231,50050247,50050403,50050418,50050460,...
- Reason
- We have discovered that, at our manufacturing facility, due to a malfunction in the program performing automatic inspections of oxygen concentration instrument error (the difference between the sensor readings inside the device and the measurements taken by the oxygen concentration meter), the system was unable to obtain valid readings depending on the timing of sensor readings. As a result, invalid values were recorded in the manufacturing logs, and products were shipped without these values being subject to quality inspection. We have conducted oxygen concentration tests on the affected...
- 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/ec61fd64-b07e-46af-9987-f0eefe24285b