Recall Z-1268-2020 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Pentax of America Inc
Pentax Video Colonoscope Model: EC38-i10L
| Date | Jan 3, 2020 |
| Status | Terminated |
| Reason | Distributed in the USA without an approved 510K |
| Root cause | Mixed-up of materials/components |
| 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 u |
| Quantity | 1 unit |
| Distribution | NC, MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131855 | PENTAX VIDEO COLONOSCOPES (EC FAMILY) Pentax Medical Company, Apr 9, 2014 |