Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to s...

FDA Recall #Z-0628-2013 — Class II — December 18, 2012

Recall #Z-0628-2013 Date: December 18, 2012 Classification: Class II Status: Terminated

Product Description

Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, 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. The affected beds 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

9

Distribution

Worldwide Distribution - Nationwide and Canada

Code Information

Model 3002SEX, Serial Number 120315371-120315379

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated