FDA-Device2016-09-28Class II
Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Pentax of America Inc
Hazard
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
Sold states
Nationwide Distribution
Affected count
1719 units
Manufactured in
3 Paragon Dr, Montvale, NJ, United States
Products
Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2875-2016Don't want to check this manually?
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