International safety notice
As a result of an investigation at an overseas manufacturer, it was found that the welded part of the Autoguide tracker, which is a component of this product, It has been discovered that there is a risk of parts separating. We have decided to carry out a voluntary recall of the affected lot products.
Japan / PMDA Recalls · JPN · Nov 12, 2021
Key facts
| Title | As a result of an investigation at an overseas manufacturer, it was found that the welded part of the Autoguide tracker, which is a component of this product, It has been discovered that there is a risk of parts separating. We have decided to carry out a voluntary recall of the affected lot products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Neurosurgical navigation unit Sales name: Stealth Autoguide |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 210115, 210511, 210113, 9736188, 201102, 210518, 210504, 201203, 201103, 210519, 201206, 200903 and 1 more |
| Date | Nov 12, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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