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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.

FDA Recall Z-2875-2016 · Posted None

Recalling FirmPentax of America Inc
Recall StatusTerminated
Product CodeEOQ
Date Initiated2016-05-31
Date Terminated2017-12-21
Product Quantity1719 units

Reason for Recall

Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.

Firm Action

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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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