Recall Z-2448-2021— Pentax of America Inc
Class II · Ongoing
Class II FDA medical device recall by Pentax of America Inc, initiated 2021-07-14. It names 3 FDA 510(k) clearances: K210485, K181084, K131855. Product: Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK. Reason: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families.
- Recalling firm
- Pentax of America Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-07-14
- Firm location
- Montvale, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K210485 — PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
- K181084 — PENTAX Video Colonoscopes (EC Family)
- K131855 — PENTAX VIDEO COLONOSCOPES (EC FAMILY)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
Reason for recall
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Data sourced from openFDA. This site is unofficial and independent of the FDA.