International safety notice
A report from our subcontractor revealed that the circuit board contained components that were different from those in the certified configuration. It has become clear. We will carry out a voluntary recall for this purpose.
Japan / PMDA Recalls · JPN · Nov 12, 2024
Key facts
| Title | A report from our subcontractor revealed that the circuit board contained components that were different from those in the certified configuration. It has become clear. We will carry out a voluntary recall for this purpose. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Active extension/flexion/extension rotation exercise device Sales name: HAL medical single joint type |
| Manufacturer | C Y B E R D Y N E Co., Ltd. |
| Models | SB0248, SB0070, SB015, SB0247, SB0129, SB0024, SB0203, SB0074, SB0288, SB0028, SB0289, SB0176 and 104 more |
| Date | Nov 12, 2024 |
| 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