Generic Name: Continuous-action Pneumatic Massager, Intermittent-action Pneumatic Massager — Trade Name: Scd Smart Flow
- Recalling firm
- Name of Manufacturer/Distributor: Cardinal Health Co., Ltd. — Address of Manufacturer/Distributor: 1217-1 Tomonaga, Fukuroi City, Shizuoka Prefecture — Type of License: Class I Medical Device...
- Product
- Lot: 出荷数量：1,116台 出荷時期：令和6年12月16日〜令和7年4月21日 カタログ番号：82107 製造番号： F2406550、F2406551、F2406555、F2406557、F2406558、F2406564、F2406565、F2406566、F2406568、F2406569、 F2406570、F2406571、F2406572、F2406573、F2406574、F2406575、F2406576、F2406577、F2406578、F2406579、 F2406580、F2406581、F2406582、F2406583、F2406584、F2406585、F2406586、F2406587、F2406588、F2406589、 F2406591、F2406592、F2406593、F2406594、F2406595、F2406596、F2406597、F2406598、F2406600、F2406601、 F2406605、F2406606、F2406609、F2406610、F2406611、F2406614、F2406617、F2406618、F2406620、F2406621、...
- Reason
- One of the alarm functions of the SCD Smart Flow unit (82107) is the "E1 System High Pressure Alarm." Normally, this alarm sounds when high pressure is reached due to a blockage in the flow path or similar issues. However, we have confirmed that an E1 error may occur when using the Comfort Sleeve Knee-Length Size S (84021) due to a software defect in the product, even under normal conditions where there is no high pressure. Therefore, we have decided to conduct a voluntary recall (repair) for the affected products as soon as preparations for the software update are complete.
- 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/9d89a4d3-5174-4402-8d83-b37052de6c81