FDAFDA · Food and drugs·Recall number Z-0617-2014
Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.
Published January 8, 2014 · Recall initiated: November 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America.
- Lot
- Models: 3002 EX, 3002 KCI, 3002 CUSTOM, 3002 ZOOM, 3002000000, and 3002 ZX-SB. And Serial Numbers: 060215711 , 060215712 , 060215713 , 060215714 , 060215715 , 060215716 , 060215717 , 060215718 , 060215719 , 060215720 , 060215721 , 060215722 , 060215723 , 060215724 , 060215725 , 060215726 , 060215727 , 060215728 , 060215729 , 060215730 , 060215731 , 060215732 , 060215733 , 060215734 , 060215735 , 060215736 , 060215737 , 060215738 , 060215739 , 060215740 , 060215741 , 060215742 , 060215743 , 060215744 , 060215761 , 060215762 , 060215763 , 060215764 , 060215765 , 060215766 , 060215767 , 060215768 , 060215769 , 060215770 , 060215771 , 060215772 , 060215773 , 060215774 , 060215775 , 060215776 , 060215777 , 060215778 , 060215779 , 060215780 , 060215781 , 060215782 , 060215783 , 060215784 , 060215785 , 060215786 , 050916199 , 060515187 , 080615291 , 080615292 , 080615293 , 080615294 , 080615295 , 080615296 , 080615297 , 080615298 , 080615299 , 080615300 , 080615301 , 080615302 , 080615303 , 080615304 , 080615305 , 080615306 , 080615307 , 080615308 , 080615309 , 080615310 , 080615311 , 080615312 , 050815989 , 050815990 , 050815991 , 050815992 , 050815993 , 050816164 , 050816165 , 050816166 , 050816167 , 050816168 , 050816169 , 050816170 , 050816171 , 050816172 , 050816173 , 050816174 , 050816175 , 050816176 , 050816177 , 050816178 , 050816179 , 050816180 , 050816181 , 050816182 , 050816183 , 050816184 , 050816185 , 050816186 , 050816187 , 050816188 , 050816189 , 050816190 , 050816191 , 050816192 , 050816193 , 050816194 , 050816195 , 050816196 , 050816197 , 050816198 , 050816199 , 050816200 , 050816201 , 050816202 , 050816203 , 050816204 , 050816205 , 050816206 , 050816207 , 050816208 , 050816443 , 050816444 , 050816445 , 050816446 , 050816447 , 050816448 , 050816449 , 050816450 , 050816451 , 050816452 , 050816453 , 050816454 , 050816455 , 050816456 , 050816457 , 050816458 , 050816460 , 050816461 , 050816462 , 050816463 , 050816464 , 050816465 , 050816466 , 050816467 , 051015830 , 051015831 , 051015832 , 051015833 , 051015834 , 051015835 , 051015836 , 051015837 , 051015838 , 051015839 , 051015840 , 051015841 , 051015842 , 051015843 , 051015844 , 051015845 , 051015846 , 051015847 , 051015848 , 051015849 , 051015850 , 051015851 , 051015852 , 051015853 , 051015854 , 051015855 , 051015856 , 051015857 , 060915123 , 060915124 , 060915125 , 060915126 , 070416726 , 070817045 , 080215003 , 080215004 , 080215007 , 080215011 , 080215012 , 080415722 , 080415731 , 080615855 , 090515943 , 090515945 , 090515992 , 090515993 , 090515994 , 090515995 , 090515997 , 090515999 , 090516000 , 090516001 , 090516002 , 090516004 , 090516005 , 090516008 , 090516010 , 090516014 , 070217581 , 070816127 , 070816130 , 070816132 , 070817054 , 070817055 , 070817056 , 070817058 , 070817060 , 070817063 , 070817065 , 070817066 , 070817067 , 070817068 , 070817069 , 070817073 , 070817074 , 070915523 , 070916268 , 070916282 , 070916306 , 071015109 , 071015127 , 071217136 , 071217137 , 080215220 , 080215222 , 080215227 , 080216899 , 060615918 , 050516142 , 050516143 , 050516144 , 050516145 , 050516146 , 050516147 , 050516148 , 050516149 , 050516150 , 050516151 , 050516152 , 050516153 , 050516154 , 050516155 , 050516156 , 050516157 , 050516158 , 050516159 , 050516160 , 050516161 , 050516162 , 050516163 , 050516164 , 050516165 , 050516166 , 050516167 , 050516168 , 050516169 , 050516170 , 050516171 , 050616204 , 050616210 , 05061621
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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