Generic Name: Gas Insufflator For Laparoscopy Trade Name: (1) High Speed Insufflator Uhi (2) High Speed Insufflator Uhi-2 (3) High Speed Insufflator Uhi-3
- Recalling firm
- Name of manufacturer: Olympus Medical Systems Corporation Hachioji Office Location of manufacturer: 2951 Ishikawa-machi, Hachioji-shi, Tokyo Type of license: Type 1 medical device manufacturer and...
- Product
- Lot: 型番 ：UHI シリアル番号 ： 7400014,7400028,7400101,7400103,7400155,7400156,7400157,7400165,7400169,7400183, 7400184,7400199,7400204,7400213,7400220,7400257,7400364,7400376,7400379,7400382, 7400390,7400398,7400401,7400402,7400408,7400416,7400419,7400421,7400429,7400430, 7400440,7400447,7400448,7400463,7400475,7500493,7500538,7500577,7500587,7500589, 7500598,7500606,7500610,7500615,7500619,7500641,7500671,7500675,7500679,7500685, 7500686,7500692,7500693,7500713,7610882,7610907,7610910,7610928,7610939,7610944, 7610954,7610964,7610966,7610969,7610994,7610997,7611026,7611027,7611028,7611030,...
- Reason
- It was discovered that a software algorithm in the UHI, UHI-2, and UHI-3 could cause abdominal overpressure. In light of this situation, the decision was made to recall the products.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Recall date
- 2026-02-24
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/643bc58b-b30b-45b6-9e03-98a8401aeaef