Sechrist Hyperbaric Chamber Gurney, Standard Gurney Without Siderails & Stretcher Model, P/N 21487, Sechrist Industries,

FDA device recall Z-0737-2008 · posted 2008-01-18 · Terminated

Recall details

Recalling firm

Sechrist Industries Inc

Reason for recall

Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical)

Action taken

Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction. The Notification letter instructed their customers to: 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 brakes are working properly. The brake function may be checked by engaging the brake pedal and pushing on each end of the gurney to make sure that casters are locked securely. 4. Remove the gurneys with non-functioning brakes from service until brake cams have been replaced and brakes are fully functional. 5. Contract Sechrist for the replacement parts package. 6. Complete the retrofit of the Gurney. 7. Verify correct function of the brake assembly following retrofit. 8. Complete and send the Correction Verification Form contained in the package to Sechrist.

Root cause

Device Design

Status

Terminated

Product code

FPO

Quantity affected

559 Units Total (483 in US) for all models

Distribution

Worldwide-USA, Brazil, Bulgaria, Canada, Dubai, U.A.E., Estonia, India, Indonesia, Japan, Malaysia, Saudi Arabia, Sweden, Taiwan, Thailand, and Vietnam.

Date initiated

2007-10-31

Date posted

2008-01-18

Date terminated

2012-04-19

Location

Anaheim, CA