International safety notice
Between July and September 2021, we received multiple reports that the puncture needle could not be fixed due to idle rotation of the fixing nut, and we contacted the manufacturer. As a result of investigating the cause, we found that in a particular lot of this product, wear and tear of jigs used in the manufacturing process and inappropriate supply were found. It was discovered that this problem was caused by a component. Although we do not anticipate any health damage to patients due to this defect, we do not believe that the product will be able to demonstrate its effectiveness due to this defect. As a result, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Oct 5, 2021
Key facts
| Title | Between July and September 2021, we received multiple reports that the puncture needle could not be fixed due to idle rotation of the fixing nut, and we contacted the manufacturer. As a result of investigating the cause, we found that in a particular lot of this product, wear and tear of jigs used in the manufacturing process and inappropriate supply were found. It was discovered that this problem was caused by a component. Although we do not anticipate any health damage to patients due to this defect, we do not believe that the product will be able to demonstrate its effectiveness due to this defect. As a result, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Body surface ultrasound probe cover Sales name: Shibuco VirtuTRAX bracket |
| Manufacturer | Century Medical Co., Ltd. |
| Models | A130252, A135587, A139478, A112392, A119765, A140660, A116720, A104504, A124861, A125980, A120039, A132622 and 18 more |
| Date | Oct 5, 2021 |
| 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