Generic Name: Automated External Defibrillator For Non-medical Personnel — Trade Names: (1) Samaritan Pad 350p — (2) Samaritan Pad 360p — (3) Samaritan Pad 450p
Recall Summary Certain Samaritan PAD automated external defibrillators (models 350P, 360P, and 450P) are being recalled because manufacturing changes made to meet European environmental standards may cause defects in internal circuit components that could prevent the device from delivering an electric shock when needed. Although the defect rate is very low and no failures have been reported in actual use, the recall is being issued for safety reasons. The recall affects specific serial numbers of devices distributed by Nippon Stryker Co., Ltd.
- Recalling firm
- Name of Manufacturer and Distributor: Nippon Stryker Co., Ltd. — Address of Manufacturer and Distributor: 1-1, 5-chome, Nishi-Shinjuku, Shinjuku-ku, Tokyo — License Type: Type I Medical Device...
- Product
- Lot: (1) サマリタン ＰＡＤ ３５０Ｐ 品番:350-STR-JA-10 対象シリアル番号: 23D90000295D23, 23D90000297D23, 23D90000298D23, 23D90000299D23, 23D90000300D23, 23D90000301D23, 23D90000302D23, 23D90000304D23, 23D90000305D23, 23D90000306D23, 23D90000307D23, 23D90000308D23, 23D90000309D23, 23D90000310D23, 23D90000311D23, 23D90000312D23, 23D90000313D23, 23D90000314D23, 23D90000315D23, 23D90000316D23, 23D90000317D23, 23D90000318D23, 23D90000319D23, 23D90000320D23, 23D90000321D23, 23D90000322D23, 23D90000323D23, 23D90000324D23, 23D90000325D23, 23D90000326D23, 23D90000327D23, 23D90000328D23, 23D90000329D23, 23D90000330D23,...
- Reason
- This product is an automated external defibrillator (AED) designed for use by laypeople to perform defibrillation on patients experiencing sudden cardiac arrest by delivering an electric shock through adhesive electrode pads. Extensive quality testing conducted by the manufacturer has confirmed that modifications made to the manufacturing process to comply with European environmental regulations (RoHS) may cause malfunctions in the printed circuit board components inside the unit, potentially resulting in the device being unable to deliver an electric shock. Although the incidence rate...
- Classification
- Class I
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/cf0f5517-cabc-46e3-b512-101116eb8359