International safety notice

The ZedKnee and JIGEN modules within ZedView simulate the placement of femoral components. When displaying the angle of ``rotation (TEA),'' which is one of the parameters referenced when We have discovered a problem in which "external rotation xx degrees (°)" is always incorrectly displayed even when the We will apply the corrected software and carry out collection work.

Japan / PMDA Recalls · JPN · Aug 26, 2022

Key facts

Title The ZedKnee and JIGEN modules within ZedView simulate the placement of femoral components. When displaying the angle of ``rotation (TEA),'' which is one of the parameters referenced when We have discovered a problem in which "external rotation xx degrees (°)" is always incorrectly displayed even when the We will apply the corrected software and carry out collection work.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Program for general-purpose diagnostic imaging equipment workstations Sales name: ZedView
Manufacturer Lexi Co., Ltd.
Models ver.16.0.0
Date Aug 26, 2022
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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

Browse all International device safety notices