International safety notice
During our in-house operation checks of equipment manufactured by foreign manufacturers, we discovered that the earth leakage breaker did not work properly. Ta. An investigation into the cause revealed that the wiring for the earth leakage breaker was different from the electrical wiring diagram. Due to insufficient confirmation of the wiring of the earth leakage breaker at the foreign manufacturer, we confirmed the wiring of the earth leakage breaker, If the wiring is incorrect, we will conduct a voluntary recall to change the wiring to the correct one or replace the device with one with the correct wiring.
Japan / PMDA Recalls · JPN · Oct 3, 2022
Key facts
| Title | During our in-house operation checks of equipment manufactured by foreign manufacturers, we discovered that the earth leakage breaker did not work properly. Ta. An investigation into the cause revealed that the wiring for the earth leakage breaker was different from the electrical wiring diagram. Due to insufficient confirmation of the wiring of the earth leakage breaker at the foreign manufacturer, we confirmed the wiring of the earth leakage breaker, If the wiring is incorrect, we will conduct a voluntary recall to change the wiring to the correct one or replace the device with one with the correct wiring. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cleaner for instrument decontamination Sales name: BLUNIX Washer Disinfector |
| Manufacturer | Sakura Seiki Co., Ltd. |
| Models | B60TL119, B60UB128, B60SI076, B60TL107, B60SI074, B60UB122, B60TL121 |
| Date | Oct 3, 2022 |
| 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