GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care enviro

FDA device recall Z-1859-2012 · posted 2012-06-22 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

Action taken

The firm, Stryker Medical, sent an "URGENT- Medical Device Correction" letter dated May 17, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to observe the beds for any malfunctions according to Preventive Maintenance Checklists in maintenance manual; report scale or bed exit malfunctions to Stryker (1-800-327-0770, option 2) to arrange for field service or to order service parts, at no charge. The customers were also instructed to forward this notice and advise Stryker of any subaccounts if the product was further distributed. A postage paid return postcard is to be filled for tracking and to make arrangements for repair. If you have any urgent questions or concerns, call 269-389-6466, Monday-Friday 8a.m-5p.m. (ET).

Root cause

Component design/selection

Status

Terminated

Product code

FNL

Quantity affected

6325

Distribution

Worldwide distribution:USA (nationwide) and countries including: Argentina, Bertec, Brasil, Brazil, Canada, Chile, China, India, Latin America, Mexico,Osteonics SA, Polska, Portugal, Puerto Rico, and

Date initiated

2012-05-17

Date posted

2012-06-22

Date terminated

2014-05-12

Location

Portage, MI