Recall Z-0629-2013— Stryker Medical Division of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2012-12-18, terminated 2013-08-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-18
- Terminated
- 2013-08-30
- Firm location
- Portage, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.