Device product
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.
Z-2875-2016
Product summary
- Event
- Event 74954
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1719 units
- Official record key
device-enforcement:Z-2875-2016
Official wording
Reason: Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
Code information: EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.