International safety notice
A medical institution confirmed that the product was fixed to a base, matched to the patient's body shape, cured at low temperature, and then reattached to the patient. It was pointed out that the product shrinks more strongly than conventional products and cannot be fixed to the base. Since we cannot deny that the product is different from the original product, we will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Apr 3, 2023
Key facts
| Title | A medical institution confirmed that the product was fixed to a base, matched to the patient's body shape, cured at low temperature, and then reattached to the patient. It was pointed out that the product shrinks more strongly than conventional products and cannot be fixed to the base. Since we cannot deny that the product is different from the original product, we will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Patient positioning device for head and neck imaging diagnosis and radiotherapy Brand name: Create fixed shell (for head/head and neck) |
| Manufacturer | Muranaka Medical Equipment Co., Ltd. |
| Models | 221105111129, 221029111099, M88-002-07, YC-M10-201MHW-07, YC-M10-201MHW-09, M88-002-08, 221028111099, YC-M10-201MIW-07, M88-002-06, YC-M10-201MIW-09, M88-002-04, M88-002-09 and 1 more |
| Date | Apr 3, 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