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U.S. Department of Health and Human Services

Class 2 Device Recall Sechrist Hyperbaric Chamber Gurney.

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 Class 2 Recall
Sechrist Hyperbaric Chamber Gurney.
see related information
Date Posted January 19, 2012
Recall Status1 Terminated on January 19, 2012
Recall Number Z-0816-2012
Recall Event ID 60466
Product Classification Stretcher, Wheeled - Product Code FPO
Product Sechrist Hyperbaric Chamber Gurney. The Sechrist Hyperbaric Chamber Gurney is an accessory device to the Sechrist Monoplace Hyperbaric Chambers. It is intended solely for the loading and unloading of patients into Sechrist Monoplace Hyperbaric Chambers. It is not intended for general hospital patient transport and is sold only to be used in conjunction with Sechrist Monoplace Hyperbaric Chambers.
Code Information Models 722, 734, 736, 737, 738, 1007, 1027, and 1079 Stryker Medical Street
Recalling Firm/
Manufacturer
Sechrist Industries Inc
4225 E La Palma Ave
Anaheim, California 92807-1815
Manufacturer 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
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action 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. .
Quantity in Commerce 198
Distribution Worldwide Distribution -- USA (nationwide) and the countries of Peru, Venezuela, Brazil, Egypt, Mexico, Austrailia, Denmark and Taiwan
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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