FDA Device recall Z-0439-2019
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option by Stryker Medical Division, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0439-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-08 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Medical Division |
| Distribution | 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, WY |
Product
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
Reason
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.
Identifiers
| code_info | Serial Numbers: 025414 026524 026525 026526 026527 030552 030553 030554 030555 030556 027441 034418 034419…Serial Numbers: 025414 026524 026525 026526 026527 030552 030553 030554 030555 030556 027441 034418 034419 034420 041189 041190 042791 042792 042793 042794 042795 042796 042797 042798 042799 042800 042801 042802 042803 042804 042805 042806 042807 042808 042809 042810 042811 042812 042813 042814 042815 042816 042817 042818 042819 042820 042821 042822 042823 042824 042825 042826 042827 042828 046459 046992 046993 047150 047151 048208 048209 048210 048211 048212 048213 048214 048215 048216 048217 048681 048682 032798 032799 032800 032801 032802 032803 032804 032805 032806 032807 032808 032809 032810 032811 032812 032813 032814 032815 032816 032817 032818 032819 032820 032821 032822 032823 032824 033942 033943 033944 034417 034530 034531 034532 034533 034534 034535 034536 034537 034538 034539 034579 034580 034581 035059 035174 035175 035207 035208 036925 036926 036927 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0439-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.