The Spirit Plus Bed recalled over entrapment hazard

Recall date

October 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Medical Division of Stryker Corporation recalls The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

Recall number

Z-0438-2019

FDA classification

Class II

Brand / firm

Stryker Medical Division of Stryker Corporation

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option