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Recall Observatory FDA recall evidence

Device product

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.

Z-0629-2013

December 18, 2012

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 63602
Status
Terminated
Classification
Class II
Quantity
1004
Official record key
device-enforcement:Z-0629-2013

Official wording

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 information: Model 3005S3EX, Serial Number 120415087 - 120515468,

Distribution pattern: Worldwide Distribution - Nationwide and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.