FDA Enforcement Class II Terminated

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.

Recall: Z-0629-2013 · Reported January 9, 2013

Enforcement

Recall Number
Z-0629-2013
Event ID
63602
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Stryker Medical Division of Stryker Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date
January 9, 2013
Initiation Date
December 18, 2012
Classification Date
January 3, 2013
Termination Date
August 30, 2013
Address
3800 East Centre Ave., N/A, Portage, MI, 49002, United States

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

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.

Code Info

Model 3005S3EX, Serial Number 120415087 - 120515468,

Distribution

Worldwide Distribution - Nationwide and Canada

Quantity

1004