Recall Z-0438-2019— Stryker Medical Division of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2018-10-08, terminated 2020-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option. Reason: 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..
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-08
- Terminated
- 2020-04-28
- Firm location
- Portage, MI, United States
Product description
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.