International safety notice
Post-market surveillance identified issues related to the safe use of this product. Related to rings. During the process of solidification of paraffin in the paraffin tank, the tank may become deformed, resulting in the sealing of the tank. The ring may break. paraffin can enter the housing, resulting in paraffin seeping into the insulation. material may fall onto the printed circuit board assembly and primary circuitry. Thermal materials do not maintain flame retardancy, and toxic smoke may be generated inside the product, potentially causing a fire, so we are conducting a voluntary recall. vinegar.
Japan / PMDA Recalls · JPN · Jun 4, 2024
Key facts
| Title | Post-market surveillance identified issues related to the safe use of this product. Related to rings. During the process of solidification of paraffin in the paraffin tank, the tank may become deformed, resulting in the sealing of the tank. The ring may break. paraffin can enter the housing, resulting in paraffin seeping into the insulation. material may fall onto the printed circuit board assembly and primary circuitry. Thermal materials do not maintain flame retardancy, and toxic smoke may be generated inside the product, potentially causing a fire, so we are conducting a voluntary recall. vinegar. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Sample pretreatment device Sales name: Leica ArcadiaH |
| Manufacturer | Leica Microsystems Co., Ltd. |
| Models | SN1127, SN482, SN221, SN224-227, SN104, SN902, SN648, SN823, SN744, SN908, SN707-708, SN1120-1121 and 16 more |
| Date | Jun 4, 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