International safety notice
The adult SMART pad cartridge used exclusively for the Philips AED HeartStart HS1 When you remove the pad inside the cartridge from the backing paper (yellow plastic liner), Cases where the gel peeled off from the surface were confirmed. Regarding the contents, Philips headquarters overseas has provided information on SMART pads for adults and for preschoolers with a similar structure. After receiving notification that a market safety notice would be distributed to target facilities for cartridges to alert them, Japan In Japan, market safety notices were distributed to raise awareness. We are currently preparing to manufacture, ship, and introduce SMART pads and cartridges for preschoolers that have resolved this issue in Japan. Because of this, we are targeting all SMART pads and cartridges for preschoolers in the domestic market that are within their expiry date. We will carry out the replacement work as a voluntary recall.
Japan / PMDA Recalls · JPN · Jun 23, 2023
Key facts
| Title | The adult SMART pad cartridge used exclusively for the Philips AED HeartStart HS1 When you remove the pad inside the cartridge from the backing paper (yellow plastic liner), Cases where the gel peeled off from the surface were confirmed. Regarding the contents, Philips headquarters overseas has provided information on SMART pads for adults and for preschoolers with a similar structure. After receiving notification that a market safety notice would be distributed to target facilities for cartridges to alert them, Japan In Japan, market safety notices were distributed to raise awareness. We are currently preparing to manufacture, ship, and introduce SMART pads and cartridges for preschoolers that have resolved this issue in Japan. Because of this, we are targeting all SMART pads and cartridges for preschoolers in the domestic market that are within their expiry date. 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 for preschoolers |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | Y032522-12, Y081222-04, Y031122-01, Y111721-03, M5072A, Y020121-02, Y022422-10, Y111022-12, Y031621-03, Y120122-16, Y062122-11, Y011421-01 and 2 more |
| Date | Jun 23, 2023 |
| 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