International safety notice
As a result of investigating defect reports received from the market at overseas manufacturers, we found that the arm of this product may not be able to be fixed. This has been confirmed. The arm will be fixed in place by pulling the arm forward, but you should not rotate the knob while pulling the arm forward or move the knob rapidly with strong force. It was concluded that if the product were rotated, the screws inside the product would not engage and the arm would no longer be able to be fixed. For this reason, overseas manufacturers have begun voluntary recall measures for all products within the expiry date. has decided to launch similar voluntary recall measures.
Japan / PMDA Recalls · JPN · Dec 20, 2023
Key facts
| Title | As a result of investigating defect reports received from the market at overseas manufacturers, we found that the arm of this product may not be able to be fixed. This has been confirmed. The arm will be fixed in place by pulling the arm forward, but you should not rotate the knob while pulling the arm forward or move the knob rapidly with strong force. It was concluded that if the product were rotated, the screws inside the product would not engage and the arm would no longer be able to be fixed. For this reason, overseas manufacturers have begun voluntary recall measures for all products within the expiry date. has decided to launch similar voluntary recall measures. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use retractor Sales name: ACROBAT-i positioner |
| Manufacturer | Getinge Group Japan Co., Ltd. |
| Models | 3000225769, 3000214052, XP-5000Z, 3000231210 |
| Date | Dec 20, 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