Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is i...
FDA Recall #Z-0629-2013 — Class II — December 18, 2012
Product Description
Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls.
Reason for Recall
Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.
Recalling Firm
Stryker Medical Division of Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1004
Distribution
Worldwide Distribution - Nationwide and Canada
Code Information
Model 3005S3EX, Serial Number 120415087 - 120515468,
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated