EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Pulmonary Tract.
FDA Recall Z-0818-2012 · Posted 2012-01-20
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Recalling FirmPentax Medical Company
Recall StatusTerminated
Product CodeEOQ
Date Initiated2011-09-30
Date Terminated2012-11-27
Product Quantity18 units
Reason for Recall
The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.
Firm Action
Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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