International safety notice
As a result of an investigation at an overseas manufacturer, the number of reports of defects such as tip breakage, blurring, and vibration regarding a specific lot of products has increased. It has been found that the number is increasing. point of Although the investigation has not yet determined the cause, there is a risk of health damage caused by this event. Autonomy We have decided to carry out a recall.
Japan / PMDA Recalls · JPN · Sep 1, 2021
Key facts
| Title | As a result of an investigation at an overseas manufacturer, the number of reports of defects such as tip breakage, blurring, and vibration regarding a specific lot of products has increased. It has been found that the number is increasing. point of Although the investigation has not yet determined the cause, there is a risk of health damage caused by this event. Autonomy We have decided to carry out a recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: shaver system Brand name: (1) ENT Blade (for otorhinolaryngology/orthopedics) (2) EM blade |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 1883080HRE, 0220703986, 0220266094, 0220929477, 1884013, 0218322548, 0218354891, 0218356098, 0221477063, 0219728473, 0221477053, 0218283720 and 224 more |
| Date | Sep 1, 2021 |
| 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