International safety notice

Common name: General purpose ultrasound imaging device Brand name: Ultrasound imaging device EPIQ/Affiniti

Japan / PMDA Recalls · JPN · Aug 6, 2021

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: General purpose ultrasound imaging device Brand name: Ultrasound imaging device EPIQ/Affiniti
Manufacturer Philips Japan Co., Ltd.
Models US221B0005,US221B0196,US221B0361,US221B0362,US221B0553,US221B0554,US221B0669,US221B0774,, US321B0416,US321B0608,US321B0877,US321B1131,US321B1255,US321B1751,US321B2165,US321B2166,, US820C1812,US914B0838,US919C1962,US920B0144,US920B0198,US920B0308,US920B0352,US920B0353,, US620B1065,US620B1405,US620B1897,US620B1931,US714B0189,US714B0190,US718B1346,US720B0236,, US320B1567,US320B1734,US320B1855,US320C1727,US321B0252,US321B0358,US321B0414,US321B0415,, US121B0534,US121B0733,US121B0734,US121B0735,US121B0784,US121B0787,US121B0788,US121B0789,, US520B1470,US520B1605,US520C1325,US521B0012,US521B0100,US616B0931,US620B0100,US620B0770,, US121B1171,US121B1321,US121B1322,US121B1331,US121B1432,US121B1435,US121B1532,US121B1610,, USD20B0405,USD20B0424,USD20B0523,USD20B0796,USD20B0942,USD20B0943,USD20B0959,USD20B0963,, US920C1323,USD14B0033,USD20B0086,USD20B0087,USD20B0088,USD20B0187,USD20B0389,USD20B0396,, US221B1552,US221B1553,US221B1599,US221B1666,US221B1672,US221B1678,US221B1682,US221B1708,, USN20B0070,USN20B0316,USN20B0368,USN20B0680,USN20B0711,USN20B0712,USN20B0713,USN20B0861, and 17 more
Date Aug 6, 2021
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

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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

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