Sechrist Hyperbaric Chamber Gurney. 의 리콜

Recall

60466

Class 2

Z-0816-2012

2009-09-15

2012-01-19

Terminated

United States

2012-01-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105498

Stryker medical has received complaints from customers that indicate a bushing in the braking system may fracture, which could result in the brake/steer pedal seizing. if the pedal seizes, the braking system may become inoperable or steering around corners may come more difficult. while no injuries have been associated with these reported events nor has there been reported failure events resulting.

Sechrist Industries sent a Urgent Medical Device Correction letter dated September 9, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Locate the gurneys with the serial numbers listed in this advisory. 2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location. 3.Verify the braking system is working properly. If the brake system is inoperable, or if the brake and /or steer require a greater than normal force to engage, remove the stretcher from service and contact Stryker Medical at 800-Stryker, option 3. Reference RA-2009-135. Do not put the stretcher back into service until is repaired by the Stryker field representative. 4. Contact Stryker Medical to schedule a service call for replacement of the bushing and mating parts of the stretcher. 5.Complete retrofit of the Gurney. 6.Verify correct function of the brake assembly following retrofit. 7.Complete and send the Correction Verification Form contained with this notice to Sechrist. For further questions please call (714) 579-8400. .