International safety notice
In the SMART pad cartridge used exclusively for the Philips AED HeartStart HS1, the cart When the pad inside the ridge is peeled off from the backing paper (yellow plastic liner), the pad will come out. Cases of peeling of the rubber have been confirmed. Since we received notice that a warning will be issued, we are also distributing market safety notices in Japan to raise awareness. I was there. Now that this is in place, we will replace all SMART pads and cartridges within the expiry date in the domestic market. We will carry out the replacement work as a voluntary recall.
Japan / PMDA Recalls · JPN · Jan 16, 2023
Key facts
| Title | In the SMART pad cartridge used exclusively for the Philips AED HeartStart HS1, the cart When the pad inside the ridge is peeled off from the backing paper (yellow plastic liner), the pad will come out. Cases of peeling of the rubber have been confirmed. Since we received notice that a warning will be issued, we are also distributing market safety notices in Japan to raise awareness. I was there. Now that this is in place, we will replace all SMART pads and cartridges within the expiry date in the domestic market. We will carry out the replacement work as a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Moving electrode for removing fine particles on body surface Sales name: SMART Pad Cartridge |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | Y011521-07, Y073020-05, Y061821-02, Y033022-04, Y052722-02, Y110920-01, Y100820-11, Y062322-10, Y071122-01, Y021621-01, Y110521-13, Y111921-09 and 17 more |
| Date | Jan 16, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 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