FDA Enforcement
Class II
Terminated
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.
Recall: Z-2875-2016
·
Reported September 28, 2016
Enforcement
- Recall Number
- Z-2875-2016
- Event ID
- 74954
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Pentax of America Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 28, 2016
- Initiation Date
- May 31, 2016
- Classification Date
- September 22, 2016
- Termination Date
- December 21, 2017
- Address
- 3 Paragon Dr, Montvale, NJ, 07645-1782, United States
Description
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.
Reason
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
Code Info
EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
Distribution
Nationwide Distribution
Quantity
1719 units