Sechrist Hyperbaric Chamber Gurney. The Sechrist Hyperbaric Chamber Gurney is an accessory device to the Sechrist Monopl

FDA device recall Z-0816-2012 · posted 2012-01-19 · Terminated

Recall details

Recalling firm

Sechrist Industries Inc

Reason for recall

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

Action taken

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. .

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FPO

Quantity affected

198

Distribution

Worldwide Distribution -- USA (nationwide) and the countries of Peru, Venezuela, Brazil, Egypt, Mexico, Austrailia, Denmark and Taiwan

Date initiated

2009-09-15

Date posted

2012-01-19

Date terminated

2012-01-19

Location

Anaheim, CA