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Class 2 Device Recall Sechrist Hyperbaric Chamber Gurney. |
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Date Initiated by Firm |
September 15, 2009 |
Date Posted |
January 19, 2012 |
Recall Status1 |
Terminated 3 on January 19, 2012 |
Recall Number |
Z-0816-2012 |
Recall Event ID |
60466 |
Product Classification |
Stretcher, wheeled - Product Code FPO
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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 CA 92807-1815
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For Additional Information Contact |
714-579-8400
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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
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FDA Determined Cause 2 |
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.
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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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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