PlainRecalls
FDA Devices Moderate Class II Terminated

S3 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.

Reported: January 8, 2014 Initiated: November 26, 2013 #Z-0618-2014

Product Description

S3 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.

Reason for Recall

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.

Details

Units Affected
108,769 Total
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America.
Location
Portage, MI

Frequently Asked Questions

What product was recalled? ▼
S3 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.. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 108,769 Total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2014. Severity: Moderate. Recall number: Z-0618-2014.

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