Recall Z-0453-2013 ยท GEX Powered Laser Surgical Instrument
OmniGuide, Inc.
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,
| Date | Dec 3, 2012 (initiated Nov 5, 2012) |
| Status | Terminated |
| Reason | Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient |
| Root cause | Process control |
| 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 | 45 units |
| Distribution | Nationwide Distribution including AZ, FL, MA, NY, OH, and OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070157 | OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER Omniguide, Inc., Feb 1, 2007 |