Generic Name: Oxygen Concentrator (respiratory-synchronized Regulator) — Trade Name: Hi-san Portable Α
- Recalling firm
- Name of Manufacturer and Distributor: Teijin Pharma Limited — Address of Manufacturer and Distributor: Kasumigaseki Common Gate West Tower, 3-2-1 Kasumigaseki, Chiyoda-ku, Tokyo — Type of License:...
- Product
- Lot: 対象装置製造番号 HW129X0020 HW12BX0003 HW12BX0015 HW12CX0018 HW12CX0022 HW12CX0048 HW12CX0059 HW12CX0060 HW12CX0064 HW12CX0068 HW12CX0104 HW12CX0108 HW131X0021 HW131X0062 HW132X0014 HW132X0089 HW133X0017 HW133X0018 HW133X0024 HW133X0034 HW133X0056 HW133X0067 HW133X0084 HW138X0002 HW138X0015 HW13AX0047 HW13AX0057 HW13AX0072 HW13AX0094 HW13AX0114 HW13BX0007 HW13BX0025 HW13BX0055 HW13BX0071 HW13BX0081 HW13CX5003 HW13CX5005 HW13CX5027 HW141C0008 HW141C0035 HW141X5008 HW141X5010 HW142C0013 HW142C0014 HW142X5001 HW142X5003 HW142X5022 HW142X5034 HW143C0005 HW143C0006 HW143C0020 HW143X5013 HW143X5034...
- Reason
- It has been discovered that the UDI listed on the regulatory label of some of these products contains an error in the reference to the electronic package insert. Due to updates to the applicable JIS standards, two versions of this product exist—one based on the old specifications and one based on the new specifications—and electronic package inserts are provided for each version. We have confirmed that, in this instance, a regulatory label intended for the new specifications was mistakenly affixed to a product based on the old specifications. Consequently, the label directs users to the...
- Classification
- Class III
- 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/d351b66b-957b-442b-ace1-939489b76086