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Terminated

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Recall Z-0439-2019 · Posted None

Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeFNL
Date Initiated2018-10-08
Date Terminated2020-04-28

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.

Firm Action

Medical Device Correction notification letters were distributed to customers on 10/8/18.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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