International safety notice

Some tests conducted during inspections at overseas factories (targeting E-100s that have undergone annual replacement inspections) are performed on the specific serials listed above. We have confirmed that this has not been done. We have decided.

Japan / PMDA Recalls · JPN · Jun 24, 2022

Key facts

Title Some tests conducted during inspections at overseas factories (targeting E-100s that have undergone annual replacement inspections) are performed on the specific serials listed above. We have confirmed that this has not been done. We have decided.
Regulator Japan / PMDA Recalls
Country JPN
Brand General name: Active therapeutic appliances Sales name: EndoWrist Vessel Sealer System
Manufacturer Intuitive Surgical LLC
Models P120382663, P120380331, SL0682, 374848-09, SK4099, SK4156, P120360479, P120461122, P120370003, P120342112, SK3870, P120430623 and 34 more
Date Jun 24, 2022
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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