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U.S. Department of Health and Human Services

Class 2 Device Recall OmniGuide BPROBOTIC

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 Class 2 Recall
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Date Posted December 03, 2012
Recall Status1 Terminated on October 16, 2014
Recall Number Z-0453-2013
Recall Event ID 63642
Premarket Notification
510(K) Number
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy
Code Information Lot Numbers: LA121003AO-P1 LA121003AQ-P1 LA121001CB-P1 LA121003AL-P1 LA121002AC-P1 LA121001CC-P1 LA121001BZ-P1 LA121001BZ-P1 LA121001AR-P1 LA121001AQ-P1 LA121001CA-P1 LA120926BA-P1 LA120926AS-P1 LA120919BG-P1 LA120920AF-P1 LA120924AG-P1 :
Recalling Firm/
OmniGuide, Inc.
One Kendall Square
Building 100, 3rd floor
Cambridge, Massachusetts 02139-1562
For Additional Information Contact Tracy Acardi
Manufacturer Reason
for Recall
Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
FDA Determined
Cause 2
Action OmniGuide issued letter notifiction on November 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that an OmniGuide sales representative would contact them immediately to recover the affected product. For any questions customers were instructed to call 617-551-8561. For questions regarding this recall call 617-551-8410.
Quantity in Commerce 45 units
Distribution Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
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.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = OMNIGUIDE, INC.