Recall StatusTerminated
Date Initiated2010-05-14
Date Terminated2011-06-13
Product Quantity9,134
Reason for Recall
The Fowler mechanism may malfunction, preventing it from being lowered into a flat position.
Firm Action
Stryker Medical sent an Urgent Medical Device Alert letter dated May 14, 2010 to their customers. The letter identified the product, the problem, and the actions customers should take.
The letter instructed users to do the following:
" Return the postcard included with the letter to confirm receipt of the
notification.
" Locate the recalled beds, verify the Fowler mechanism is functioning properly and does
not display uneven motion when raising and lowering, and is not unusually
noisy.
" If the Fowler mechanism is not operating correctly, they were to call Stryker at
1-800-STRYKER, option 1, Reference RA-2010-014 to obtain service for the
bed.
" If any beds have been loaned or sold, the customer is to forward a copy of the
notice to the new users and advise the firm of the new location.
" Provide the firm with the serial numbers for any beds that were disposed of.
" Retain the revised maintenance manual included with the notification.
If the customer had any urgent questions or concerns, they were instructed to call the firm at 800-STRYKER, option 1, reference RA-2010-014, Monday-Friday 8am to 5pm (EST).
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution - USA (all states), and including the countries of ARGENTINA, BRAZIL, CHILE, CHINA, CANADA, MEXICO, GREECE, JAPAN, KOREA, PUERTO RICO, SPAIN, POLAND, TAIWAN, SINGAPORE, INDIA, SWITZERLAND, UK and MALAYSIA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.