Recall Z-1267-2020
Pentax of America Inc · initiated January 3, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pentax Video Colonoscope Model: EC34-i10L
Codes / lots: Serial Numbers: L110300, L110301, L110303, L110306
Reason for recall
Distributed in the USA without an approved 510K
FDA-determined 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
Details
- Recall number
- Z-1267-2020
- Initiated
- January 3, 2020
- Terminated
- January 26, 2021
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Distribution
- NC, MA
- Recalling firm
- Pentax of America Inc, Montvale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1268-2020 Class II | Pentax Video Colonoscope Model: EC38-i10LDistributed in the USA without an approved 510K | 01/03/2020Terminated |