Stryker Epic II critical care bed, 115v, Stryker Medical, Portage, MI; Model 2030. Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.
FDA Recall Z-2213-2009 · Posted 2009-09-18
Advertisement
Recalling FirmStryker Medical Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFNL
Date Initiated2009-08-10
Date Terminated2011-04-25
Product Quantity12,599 total products
Reason for Recall
The backrest of the bed may not stay in an upright position (may drift down when left raised).
Firm Action
Stryker Medical issued an "Urgent - Medical Device Correction" letter dated August 10, 2009 informing customers to locate the affected product listed and verify whether it is functioning properly. In the case the device is not properly functioning, remove from service and contact the firm as soon as possible at 1-800-STRYKER, option 3. Customers are also asked to return an enclosed return receipt post card and also forward the notification to users who have loaned or purchased the device. A representative from Stryker field service will be contacting you to perform device corrections shortly.
For further information, contact Stryker Medical at 1-269-324-6527.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement