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.
This recall has been terminated (originally issued May 31, 2016).
- Company
- Pentax Of America Inc
- Recall Initiated
- May 31, 2016
- Terminated
- December 21, 2017
- Recall Number
- Z-2875-2016
- Quantity
- 1719 units
- Firm Location
- Montvale, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
Distribution
Nationwide Distribution
Lot / Code Info
EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
Root Cause
Packaging process control
Action Taken
Pentax Medical sent a U.S. Urgent Field Correction notice to all affected customers with a recall letter/return response form on May 31, 2016 via Fed Ex. Customers with questions were instructed to call 800-431-5880, ext. 2064.
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