International safety notice

Common name: Transcutaneous blood gas analyzer/pulse oximeter combination device for monitoring biological phenomena Brand name: Transcutaneous blood gas monitor TCM5

Japan / PMDA Recalls · JPN · Oct 31, 2024

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Transcutaneous blood gas analyzer/pulse oximeter combination device for monitoring biological phenomena Brand name: Transcutaneous blood gas monitor TCM5
Manufacturer Radiometer Co., Ltd.
Models 393-500R1113N010, 393-500R1284N016, 393-500R1134N065, 393-500R1297N006, 393-500R1131N039, 393-500R1106N054, 393-500R1297N014, 393-500R1304N023, 393-500R1279N005, 393-500R1288N007, 393-500R1262N007, 393-500R1134N038 and 221 more
Date Oct 31, 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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