International safety notice
The manufacturer has informed us that the structure of the pump that sends circulating water to the dedicated garment (Cure Wrap) for the CritiCool product. Looseness of the screws that attach the product may cause pump malfunction errors, and for some products, the error may be resolved. We have received a report stating that it has been determined that there are some items that cannot be erased, and that we have decided to voluntarily make repairs. Since it has been confirmed that the affected products are contained in Japan, we have decided to carry out voluntary repairs.
Japan / PMDA Recalls · JPN · Dec 28, 2022
Key facts
| Title | The manufacturer has informed us that the structure of the pump that sends circulating water to the dedicated garment (Cure Wrap) for the CritiCool product. Looseness of the screws that attach the product may cause pump malfunction errors, and for some products, the error may be resolved. We have received a report stating that it has been determined that there are some items that cannot be erased, and that we have decided to voluntarily make repairs. Since it has been confirmed that the affected products are contained in Japan, we have decided to carry out voluntary repairs. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Water Pad Warmer System Brand name: Body temperature management system CritiCool |
| Manufacturer | Mediconovas Co., Ltd. |
| Models | 9969570200004, 9991825100004, 9979841600019, 9979841600015, 9963715800021, 9979841600002, 9982294100003, 9969414800012, 9991825100025, 9969570200020, 9971040400009, 9969414800013 and 1 more |
| Date | Dec 28, 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