Stryker Zoom Critical Care Bed, Model 2040. Stryker Medical, Kalamazoo, MI. Critical Care Patient Bed.

FDA device recall Z-2587-2010 · posted 2010-09-28 · Terminated

Recall details

Recalling firm

Stryker Medical Div. of Stryker Corporation

Reason for recall

The Fowler mechanism may malfunction, preventing it from being lowered into a flat position.

Action taken

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

Status

Terminated

Product code

FNL

Quantity affected

4,926

Distribution

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, S

Date initiated

2010-05-14

Date posted

2010-09-28

Date terminated

2011-06-13

Location

Portage, MI