Z-1267-2020 Class II Terminated
FDA device recall Z-1267-2020 was initiated by Pentax of America Inc on January 3, 2020 and is designated Class II. Reason for recall: Distributed in the USA without an approved 510K The recall status is terminated (terminated January 26, 2021).
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- January 3, 2020
- Termination Date
- January 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Pentax Video Colonoscope Model: EC34-i10L
Reason for Recall
Distributed in the USA without an approved 510K
Distribution Pattern
NC, MA
Code Information
Serial Numbers: L110300, L110301, L110303, L110306