FDA Device recall Z-0438-2019
The Spirit Plus Bed, Model 5600 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 Plus Bed, Model 5600 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-0438-2019 |
| 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 Plus Bed, Model 5600 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: 026192 026510 026511 026516 026517 026518 034095 034096 034097 034098 034099 034517 035212…Serial Numbers: 026192 026510 026511 026516 026517 026518 034095 034096 034097 034098 034099 034517 035212 035213 035214 035215 035216 035217 035218 035219 035220 035221 035222 035223 035224 035225 035226 036935 036936 036937 036938 036939 036940 036941 037995 037996 037997 037998 037999 038000 038001 038002 038003 038004 038005 038006 038126 038127 038128 039790 039791 041998 042590 044486 045322 045910 045911 045912 045913 045914 045915 045916 047581 048338 048339 048340 048341 048342 048344 048345 048346 048347 048348 034424 034425 034518 034519 034520 034521 034522 034523 034524 034525 034526 034527 034528 034529 039359 039447 039448 039449 039450 039451 039452 041416 041417 041418 041419 041420 041421 041422 041423 041424 041425 041870 041871 041872 041873 041874 041875 041876 041877 041878 041879 041880 041881 041882 041883 041884 041885 042250 042251 042252 |
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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-0438-2019%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.