International safety notice
This product is used by connecting to a centrifugal pump drive device for extracorporeal circulation equipment (hereinafter referred to as the "drive device"). We received a report from a medical institution that the product was not recognized when connected to the drive device. As a result of the investigation, it was determined that the cause was that the conductive tape inside the pressure gauge had peeled off and came into contact with the board, so we conducted a voluntary recall. vinegar.
Japan / PMDA Recalls · JPN · Apr 2, 2024
Key facts
| Title | This product is used by connecting to a centrifugal pump drive device for extracorporeal circulation equipment (hereinafter referred to as the "drive device"). We received a report from a medical institution that the product was not recognized when connected to the drive device. As a result of the investigation, it was determined that the cause was that the conductive tape inside the pressure gauge had peeled off and came into contact with the board, so we conducted a voluntary recall. vinegar. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Heart-lung machine pressure gauge Brand name: Artificial heart-lung pressure gauge PS-1 |
| Manufacturer | JMS Co., Ltd. |
| Models | 24010760TN, JM-PS1-6P-TN, 23110725TN |
| Date | Apr 2, 2024 |
| 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