The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Reported: November 21, 2018 Initiated: October 8, 2018 #Z-0438-2019
Product Description
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
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.
Details
- Recalling Firm
- Stryker Medical Division of Stryker Corporation
- Units Affected
- 20,030 total
- Distribution
- 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.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 20,030 total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 21, 2018. Severity: Moderate. Recall number: Z-0438-2019.
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