FDA-Device2014-01-08Class II
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.
Stryker Medical Division of Stryker Corporation
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.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America.
Affected count
108,769 Total
Manufactured in
3800 E Centre Ave, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0617-2014Don't want to check this manually?
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