• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall OmniGuide BPROBOTIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall OmniGuide BPROBOTICsee related information
Date Initiated by FirmNovember 05, 2012
Date PostedDecember 03, 2012
Recall Status1 Terminated 3 on October 16, 2014
Recall NumberZ-0453-2013
Recall Event ID 63642
510(K)NumberK070157 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductOmniGuide 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/
Manufacturer
OmniGuide, Inc.
One Kendall Square
Building 100, 3rd floor
Cambridge MA 02139-1562
For Additional Information ContactTracy Acardi
617-551-8561
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
Process control
ActionOmniGuide 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 Commerce45 units
DistributionNationwide Distribution including AZ, FL, MA, NY, OH, and OR.
Total Product Life CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = GEX
-
-