International safety notice
There have been reports from medical institutions that the soles of the shoes have peeled off due to this product. As a result of the investigation, it was found that the adhesive strength of the shoe sole was weakened due to the contamination of foreign matter, and there is a possibility that the same problem occurred in the above lot. Due to this, we have decided to carry out a voluntary recall (repair).
Japan / PMDA Recalls · JPN · Nov 28, 2023
Key facts
| Title | There have been reports from medical institutions that the soles of the shoes have peeled off due to this product. As a result of the investigation, it was found that the adhesive strength of the shoe sole was weakened due to the contamination of foreign matter, and there is a possibility that the same problem occurred in the above lot. Due to this, we have decided to carry out a voluntary recall (repair). |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Gait analyzer Brand name: Lower limb load cell Sokumaru IS-10 |
| Manufacturer | Duplo Seiko Co., Ltd. |
| Models | 221155922, 221155889, 221155885, 221155891, 221155880, 221155884, 221155886, 221155888, 221155920, 221155924, 221155882, 221155876 and 2 more |
| Date | Nov 28, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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