International safety notice
An issue occurred where the adapter for the MAJ-2318 water filter came off from the filter body. In the manufacturing process of water filters, due to improper assembly of the adapter, sufficient welding strength cannot be obtained and the product is removed. It turns out that it has been lost. In cases where tap water is not properly filtered and may be supplied to the endoscope washer/disinfector, the affected product must be recalled. I'm here.
Japan / PMDA Recalls · JPN · Feb 27, 2024
Key facts
| Title | An issue occurred where the adapter for the MAJ-2318 water filter came off from the filter body. In the manufacturing process of water filters, due to improper assembly of the adapter, sufficient welding strength cannot be obtained and the product is removed. It turns out that it has been lost. In cases where tap water is not properly filtered and may be supplied to the endoscope washer/disinfector, the affected product must be recalled. I'm here. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Flexible endoscope washer-disinfector Commercial name: (1) Endoscope washing and disinfection device OER-2 (2) Endoscope washing and disinfection device OER-3 (3) Endoscope cleaning and disinfection device OER-4 (4) Endoscope cleaning and disinfection device OER-S |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | 2927082, 2635356, 2048498, 2011346, 2826217, 2624528, 2121682, 2928191, 2048394, 2635474, 2523583, 2910855 and 11286 more |
| Date | Feb 27, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 100–999 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1