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Terminated

Pentax Video Colonoscope Model: EC38-i10L

FDA Recall Z-1268-2020 · Posted None

Recalling FirmPentax of America Inc
Recall StatusTerminated
Product CodeFDF
Date Initiated2020-01-03
Date Terminated2021-01-26
Product Quantity1 unit

Reason for Recall

Distributed in the USA without an approved 510K

Firm Action

Pentax Medical contacted US Affected Customers by telephone to inform them of the pending action and to advise they quarantine the affected products Pentax issued URGENT MEDICAL DEVICE CORRECTIONAND REMOVAL Letter via UPS dated 1/3/20 states: reason for recall, health risk and action to take: Please quarantine the units your facility owns, complete the response form, and return it to PENTAX Medical using the e-mail address or fax number listed below. Upon return of the response form, PENTAX will contact your facility to arrange the return of the affected units. Loaner units will be supplied until this issue is resolved. Question contact: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: [email protected]

Root Cause

Mixed-up of materials/components

Distribution Pattern

NC, MA

Official Source

View FDA Recall →

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

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