International safety notice
After contacting the manufacturer, we found out that there are three problems with the product: 1) If defibrillation is performed with this product in place, the amount of electrical energy reaching the patient may be reduced. Ru. 2) If a wet patient wearing the product comes into contact with a faulty external power source, they will be exposed to unintended voltage. there is a possibility. 3) SpO2 measurement values may become inaccurate due to foreign matter adhering to the detection unit. (Issue 3 only affects the TS-AP model of TruSignal disposable sensor.) For this reason, we are providing information to customers based on the manufacturer's information to alert them, and replacing products with fixed problems. Collection work will be carried out to replace the waste.
Japan / PMDA Recalls · JPN · Jul 13, 2023
Key facts
| Title | After contacting the manufacturer, we found out that there are three problems with the product: 1) If defibrillation is performed with this product in place, the amount of electrical energy reaching the patient may be reduced. Ru. 2) If a wet patient wearing the product comes into contact with a faulty external power source, they will be exposed to unintended voltage. there is a possibility. 3) SpO2 measurement values may become inaccurate due to foreign matter adhering to the detection unit. (Issue 3 only affects the TS-AP model of TruSignal disposable sensor.) For this reason, we are providing information to customers based on the manufacturer's information to alert them, and replacing products with fixed problems. Collection work will be carried out to replace the waste. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Names: (1)(2)(4)Reusable Pulse Oximeter Probe (3)Single Use Pulse Oximeter Probe Sales name: (1)TruSignal ear sensor (2)TruSignal sensitive skin sensor (3)TruSignal disposable sensor (4)TruSignal lap sensor |
| Manufacturer | GE Healthcare Japan Co., Ltd. |
| Models | 00421, TS-E2-GE, 22022, 04523, 30221, 28815, 32122, 27022, 32419, 36420, 08421, 34722 and 107 more |
| Date | Jul 13, 2023 |
| 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