Generic Name: General-purpose Ventilator — Trade Name: Newport Ventilator Model Ht70
- Recalling firm
- Name of Manufacturer and Distributor: Covidien Japan K.K. — Address of Manufacturer and Distributor: 1-2-70 Konan, Minato-ku, Tokyo — Type of License: Class I Medical Device Manufacturer and...
- Product
- Lot: （１）製品番号 ：HT70 対象製造番号 ：11HT700111140 11HT700311183 11HT700311196 11HT700411263 11HT700411280 11HT700511443 11HT700511444 11HT700511473 11HT700511542 11HT700811853 12HT700714316 12HT701114478 13HT700414746 13HT700414754 13HT700414755 13HT700414757 13HT700414760 13HT700615005 13HT701015202 13HT701015203 13HT701015204 13HT701015205 13HT701015208 13HT701015210 N14700315507 N14700315508 N14700315510 出荷数量 ：27台 出荷時期 ：平成23年2月9日〜 平成25年11月29日 （２）製品番号 ：HT70P 対象製造番号 ：N14720213418 N14720213425 N14720313438 N14720313439 N14720513624 N14720513628 N14720613759 N14720613769 N14720714098 N14720714103...
- Reason
- The overseas manufacturer has conducted an investigation into the following issues reported by customers regarding our product, the “Newport Ventilator Model HT70.” Issue 1: The ventilator may unintentionally shut down during use, causing ventilation to stop and potentially requiring the use of alternative ventilation methods. Issue 2: There is a possibility that the shutdown alarm may not function properly when the ventilator stops operating. Regarding these issues, an investigation by the overseas manufacturer revealed that if defects occur in each of the two different types of...
- 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/2d22b9ec-33d8-4df7-b99e-429e98ab9870