FDA-Device2018-11-21Class II
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Stryker Medical Division of Stryker Corporation
Hazard
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.
Sold states
The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The products were distributed to the following foreign countries: Canada.
Affected count
20,030 total
Manufactured in
3800 E Centre Ave, Portage, MI, United States
Products
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0438-2019Don't want to check this manually?
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