International safety notice
Reports regarding discoloration of the delivery pusher of this product have been confirmed in the market. As a result of the investigation, it was found that the flux (soldering accelerator) used in the manufacturing process was passed through the delivery pusher by the worker. It was determined that the problem was most likely caused by the product adhering to the parts of the camera. We have decided to carry out a voluntary recall of the manufacturing lots.
Japan / PMDA Recalls · JPN · Jan 12, 2024
Key facts
| Title | Reports regarding discoloration of the delivery pusher of this product have been confirmed in the market. As a result of the investigation, it was found that the flux (soldering accelerator) used in the manufacturing process was passed through the delivery pusher by the worker. It was determined that the problem was most likely caused by the product adhering to the parts of the camera. We have decided to carry out a voluntary recall of the manufacturing lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Prosthetic material for promoting embolization in blood vessels of the central circulatory system Sales name: OPTIMA coil system |
| Manufacturer | Century Medical Co., Ltd. |
| Models | F201000658, F210200034, F210200540, F201100335, F200800221, F210200165, OPTI0203CSS10, F201100399, F201100433, F210300191, OPTI0202CSS10, F210300394 and 283 more |
| Date | Jan 12, 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