FDA recall Z-1267-2020
Pentax of America Inc · Class II · device
Product
Pentax Video Colonoscope Model: EC34-i10L
Reason for recall
Distributed in the USA without an approved 510K
Distribution
NC, MA
Key facts
- Status
- Terminated
- Initiation date
- 2020-01-03
- Report date
- 2020-02-26
- Termination date
- 2021-01-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Montvale, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2020