International safety notice
An overseas manufacturer has announced that some products in affected lots may not activate even when the Energy hand control button is released. I received a message that the blade may not stop working. That's what I said.
Japan / PMDA Recalls · JPN · Jul 29, 2021
Key facts
| Title | An overseas manufacturer has announced that some products in affected lots may not activate even when the Energy hand control button is released. I received a message that the blade may not stop working. That's what I said. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Active instrument for ultrasound treatment Sales name: Harmonic HD 1000i |
| Manufacturer | Johnson & Johnson Co., Ltd. |
| Models | U95T0X, U9518D, U9548R, U95E29, U9571N, U95T90, U95754, U95F6N, U9564G, U9550G, U95814, U9503G and 47 more |
| Date | Jul 29, 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