Recall Z-0618-2014— Stryker Medical Division of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2013-11-26, terminated 2015-05-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-26
- Terminated
- 2015-05-29
- Firm location
- Portage, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.