Pentax Video Colonoscope Model: EC38-i10L
- Company
- Pentax Of America Inc
- Recall Initiated
- January 3, 2020
- Terminated
- January 26, 2021
- Recall Number
- Z-1268-2020
- Quantity
- 1 unit
- Firm Location
- Montvale, NJ
Reason for Recall
Distributed in the USA without an approved 510K
Distribution
NC, MA
Lot / Code Info
Serial Numbers:L110746
Root Cause
Mixed-up of materials/components
Action Taken
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: customeradvisories@pentaxmedical.com