[Recalled] The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option — The beds with the high rail side rail option may not be complaint with IEC 6060… | FDA 2018-10-08
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option |
|---|---|
| Brand / manufacturer | Stryker Medical Division of Stryker Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0438-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 08 October 2018 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Stryker Medical Division of Stryker Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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