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.
FDA Recall Z-0831-2012 · Posted 2012-01-20
Advertisement
Recalling FirmGulf Medical Fiberoptics, Inc.
Recall StatusTerminated
Product CodeFST
Date Initiated2011-05-13
Date Terminated2012-08-28
Product Quantity381 units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement