International safety notice
During testing of this product, the overseas manufacturer became aware that the internal wires could be damaged. is responsible for transmitting signals from the sensor to the core. If the wire is damaged and the signal is lost, no pressure reading will be displayed. However, this issue will not cause false readings. For this reason, overseas manufacturers will provide information in writing. In Japan, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Dec 18, 2024
Key facts
| Title | During testing of this product, the overseas manufacturer became aware that the internal wires could be damaged. is responsible for transmitting signals from the sensor to the core. If the wire is damaged and the signal is lost, no pressure reading will be displayed. However, this issue will not cause false readings. For this reason, overseas manufacturers will provide information in writing. In Japan, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system tip transducer catheter Sales name: OmniWire Pressure Guide Wire |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | 809535, 538503, 811762, 808718, 485577, 652017, 652007, 482723, 774371, 774470, 773769, 562667 and 2380 more |
| Date | Dec 18, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 100–999 Matching catalog numbers in FDA data
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