Recall
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…
OmniGuide, Inc. · 5 Nov 2012
- Status
- Recall terminated
- Why, in the FDA's words
- “Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient”
- Recall began
- 5 Nov 2012
- Company
- OmniGuide, Inc.
- Device type
- Product code (GEX)
- Concerns
- K070157
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.