International safety notice
For approximately two years from March 1, 2022 to March 8, 2024, the Centerra SmartPlus bed (hereinafter referred to as this product) There were 243 reports of Torres cover peeling and damage (hereinafter referred to as this incident) worldwide. As a result of an investigation by the overseas manufacturer, the possible cause of this incident was that cleaning agents containing bleach were not used when cleaning this product. It was suggested that the product had been used excessively or that the product instruction manual did not provide sufficient information regarding the correct use of the cleaning agent. I got it. In addition, when we conducted an analysis of the occurrence of this incident, we found that there was a significant increase in the 12-month incidence rate. We have decided to implement this.
Japan / PMDA Recalls · JPN · Jul 8, 2024
Key facts
| Title | For approximately two years from March 1, 2022 to March 8, 2024, the Centerra SmartPlus bed (hereinafter referred to as this product) There were 243 reports of Torres cover peeling and damage (hereinafter referred to as this incident) worldwide. As a result of an investigation by the overseas manufacturer, the possible cause of this incident was that cleaning agents containing bleach were not used when cleaning this product. It was suggested that the product had been used excessively or that the product instruction manual did not provide sufficient information regarding the correct use of the cleaning agent. I got it. In addition, when we conducted an analysis of the occurrence of this incident, we found that there was a significant increase in the 12-month incidence rate. We have decided to implement this. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: General-purpose medical treatment/treatment table Brand name: Centerra SmartPlus Bed |
| Manufacturer | Hillrom Japan Co., Ltd. |
| Models | X298PS8578, X298PS8575, X242PS4998, X242PS5004, X160PS9785, X214PS3125, X242PS5005, X298PS8598, Y249PS6293, X298PS8651, X298PS8576, X298PS8577 and 12 more |
| Date | Jul 8, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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