International safety notice

After researching overseas manufacturers, we found that the settings were originally set to ensure an appropriate flow rate when a pad was connected. Shipping a product whose flow rate may not meet the appropriate value specified in the instruction manual, even though As a result, we have decided to carry out a voluntary recall.

Japan / PMDA Recalls · JPN · Mar 11, 2024

Key facts

Title After researching overseas manufacturers, we found that the settings were originally set to ensure an appropriate flow rate when a pad was connected. Shipping a product whose flow rate may not meet the appropriate value specified in the instruction manual, even though As a result, we have decided to carry out a voluntary recall.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Water pad heating device Sales name: Arctic gel pad
Manufacturer Medicon Co., Ltd.
Models NGHP2415, NGGX1156, NGHT1139, 31802, NGHP2411, NGGX5390, NGGX1179
Date Mar 11, 2024
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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