Z-2448-2021 Class II Ongoing
FDA device recall Z-2448-2021 was initiated by Pentax of America Inc on July 14, 2021 and is designated Class II. Reason for recall: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families The recall status is ongoing. Affected quantity: 28849 units Total.
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- July 14, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28849 units Total
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
Distribution Pattern
Nationwide
Code Information
All devices distributed by Pentax in the US between April 2014 and May 2021