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Stryker Medical Division of Stryker Corporation recalls The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
Recalled November 21, 2018 · FDA recall Z-0439-2019 · Stryker Medical Division of Stryker
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. · FDA Class II
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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.
Description
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.
Product
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
Manufacturer(s)
Stryker Medical Division of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →