International safety notice

A product was found to have an abnormality in the board that amplifies the voltage used for ultrasonic oscillation. There is a possibility that the accuracy range is ±(15% + 20mL), which is the voluntary standard. I decided to collect it.

Japan / PMDA Recalls · JPN · Jul 11, 2023

Key facts

Title A product was found to have an abnormality in the board that amplifies the voltage used for ultrasonic oscillation. There is a possibility that the accuracy range is ±(15% + 20mL), which is the voluntary standard. I decided to collect it.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Bladder ultrasound imaging device Sales name: Lilium One
Manufacturer Lilium Otsuka Co., Ltd.
Models MA23020089, MA23020095, MA23010089, MA23010012, MA23010057, MA23020058, MA23030019, MA23010067, MA23010059, MA23010021, MA23010099, MA23020081 and 155 more
Date Jul 11, 2023
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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