| Class 2 Device Recall Surgical Headlight | |
Date Initiated by Firm | May 13, 2011 |
Date Posted | January 20, 2012 |
Recall Status1 |
Terminated 3 on August 28, 2012 |
Recall Number | Z-0831-2012 |
Recall Event ID |
58983 |
510(K)Number | K061690 |
Product Classification |
Light, surgical, fiberoptic - Product Code FST
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Product | Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical Headlight is a passive luminaire. It is illuminated by a source of light by way of the fiber optics and provides supplemental lighting for medical and surgical procedures. |
Code Information |
Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, GMF-H106. |
Recalling Firm/ Manufacturer |
Gulf Medical Fiberoptics, Inc. 448 Commerce Blvd. Oldsmar FL 34677
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For Additional Information Contact | Jacqueline Armand 813-855-6618 |
Manufacturer Reason for Recall | Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated. |
FDA Determined Cause 2 | Process control |
Action | On May 16, 2011, Gulf Medical Fiberoptics, Inc. issued to all customers an updated letter to their May 13, 2011 "Field Correction of Instructions For Use" informing them to discontinue the use of 70% isopropyl to clean the surfaces of the device. Enclosed with the letter was an updated Surgical Headlight User Guide with instructions to discard/shred/recycle the prior guide. The firm asked customers to return a form acknowledging the receipt and action from the letter. Customers with questions should contact Customer Service department manager Jacqueline Armand at 813-855-6618 ext. 427. |
Quantity in Commerce | 381 units |
Distribution | Worldwide Distribution - USA, including the states of FL, WI, WA, AL, CA, MO, MI, OH, VA, CO, TX, TN, NC and the countries of Turkey, Brazil, Belgium, South Korea, Panama, Mexico, Ireland, Taiwan (ROC), Italy, Argentina, India, Spain, Germany, and Venezuela. |
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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510(K) Database | 510(K)s with Product Code = FST
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