Risk of Loss of Trust Due to Defects in Medical-Related Equipment
First written in FY2016. 2 of 5 entries say "Restated". Latest entry: FY2022.
The whole theme swung hardest in 2026: 2 of 7 companies on the "Worse" side.
32 other companies' latest entry also says "Restated".
- FY2022RestatedAnnual report
「The company is working to ensure product quality by strengthening cooperation with the contract manufacturer and enhancing incoming inspections. However, although the blood collection tube preparation device is not legally classified as a medical device, it is medical-related equipment, and in the unlikely event of a product defect, the company may face reputational damage to its products and other consequences.」
The company continues to describe measures to ensure quality through cooperation with the contract manufacturer and incoming inspections, as well as the risk of reputational damage in the event of a defect. - FY2019MaterialisedAnnual report
「In May 2019, one case occurred involving a user suffering a minor burn because the sensor card used for measurement in the company’s GASTAT-navi blood analyzer became excessively hot. Users had been warned not to touch the heat-generating part of the sensor card to protect the sensor, and the company believes the likelihood of recurrence is low. However, it decided to carry out a voluntary software modification to ensure safety.」
A product defect previously disclosed as a possibility actually occurred as one case involving a minor burn caused by overheating of GASTAT-navi. The company indicated that recurrence was unlikely and decided to carry out a voluntary software modification for safety reasons. - FY2018RestatedAnnual report
「The company is working to ensure product quality by strengthening cooperation with the contract manufacturer and enhancing incoming inspections. However, although the blood collection tube preparation device is not legally classified as a medical device, it is medical-related equipment, and in the unlikely event of a product defect, the company may face reputational damage to its products and other consequences.」
The company continues to describe measures to ensure quality by strengthening cooperation with the contract manufacturer and incoming inspections, as well as the risk of reputational damage in the event of a defect. - FY2017MitigatedAnnual report
「The company is working to ensure product quality by strengthening cooperation with the contract manufacturer and enhancing incoming inspections. However, although the blood collection tube preparation device is not legally classified as a medical device, it is medical-related equipment, and in the unlikely event of a product defect, the company may face reputational damage to its products and other consequences.」
The company specifies measures to ensure quality by strengthening cooperation with the contract manufacturer and incoming inspections, providing greater detail on its response to product defect risk. - FY2016First statedAnnual report
「Although the blood collection tube preparation device is not legally classified as a medical device, it is medical-related equipment. In the unlikely event of a product defect, the company may face reputational damage to its products and other consequences.」
The company identifies the impact of product defects on its reputation as a risk associated with medical-related equipment.