Stryker Electric Stretcher with the Quick Drop CPR option, Model 1550.

FDA device recall Z-1231-2009 · posted 2009-04-05 · Terminated

Recall details

Recalling firm

Stryker Medical Div. of Stryker Corporation

Reason for recall

The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler.

Action taken

Consignees were notified by an Urgent - Medical Device Correction letter dated 2/27/09, advised of the problem and instructed to locate stretchers and verify that there is no grinding noise when activating the fowler electrically. Consignees were also instructed to remove any stretchers with a fowler that was non-operational, or which makes a grinding sound, from service until the firm makes repairs and contact the firm. Stretchers will be corrected within the next four months by a Stryker field service representative. The enclosed post card should be returned to confirm receipt of the notification. The notice should be forwarded to any users that have borrowed or purchased the stretchers and the firm should be notified of their new location. Also, if any of the affected stretchers have been disposed of or are no longer in use, the firm needs to be provided with their serial numbers. Questions or concerns should be directed to Andrea Kuthe at 269-324-6581.

Root cause

Device Design

Status

Terminated

Product code

FPO

Quantity affected

3607

Distribution

Worldwide Distribution

Date initiated

2009-02-27

Date posted

2009-04-05

Date terminated

2011-04-25

Location

Portage, MI