Stryker Epic II critical care bed, 115v, Stryker Medical, Portage, MI; Model 2030. Beds are A/C powered hospital beds th

FDA device recall Z-2213-2009 · posted 2009-09-18 · Terminated

Recall details

Recalling firm

Stryker Medical Div. of Stryker Corporation

Reason for recall

The backrest of the bed may not stay in an upright position (may drift down when left raised).

Action taken

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

Status

Terminated

Product code

FNL

Quantity affected

12,599 total products

Distribution

Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.

Date initiated

2009-08-10

Date posted

2009-09-18

Date terminated

2011-04-25

Location

Portage, MI