Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0438-2019 · Posted None

Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeFNL
Date Initiated2018-10-08
Date Terminated2020-04-28
Product Quantity20,030 total

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.

↑