International safety notice
As a result of investigating defect reports received from the market at overseas manufacturers, we found that when this product was mounted on a chest opener fixture, It has been confirmed that the engaging part of the stabilizer may be damaged and the product may fall off. When we investigated the cause of this occurrence, we found that the supplier that manufactures the housing part, which is a component of this product, Due to inadequate temperature control, residual stress was generated inside the housing after molding, making it difficult to maintain sufficient strength for use. It turned out that this was due to the inability to do so. For this reason, overseas manufacturers have begun voluntary recall measures for all products that use these parts and are still within their expiration dates. Therefore, we have decided to launch similar voluntary recall measures in Japan as well.
Japan / PMDA Recalls · JPN · Oct 6, 2023
Key facts
| Title | As a result of investigating defect reports received from the market at overseas manufacturers, we found that when this product was mounted on a chest opener fixture, It has been confirmed that the engaging part of the stabilizer may be damaged and the product may fall off. When we investigated the cause of this occurrence, we found that the supplier that manufactures the housing part, which is a component of this product, Due to inadequate temperature control, residual stress was generated inside the housing after molding, making it difficult to maintain sufficient strength for use. It turned out that this was due to the inability to do so. For this reason, overseas manufacturers have begun voluntary recall measures for all products that use these parts and are still within their expiration dates. Therefore, we have decided to launch similar voluntary recall measures in Japan as well. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use organ fixation indenter Sales name: ACROBAT-i stabilizer |
| Manufacturer | Getinge Group Japan Co., Ltd. |
| Models | 3000198652, OM-10000Z |
| Date | Oct 6, 2023 |
| 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