Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10
Summary
The FDA issued a Class II for Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i by Pentax of America Inc. Reason: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families.
Details
Source
Device Recall
External ID
Z-2449-2021
Action Date
2021-09-22
Status
Ongoing
Category
device
Product Description
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
Lot/Code Info: All devices distributed by Pentax in the US between April 2014 and May 2021
Quantity Affected: 28849 units Total
Reason for Recall
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-14
Company
Montvale, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Pentax of America Inc has 22 FDA actions in our database, including 6 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pentax of America Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pentax of America Inc have FDA actions?
Pentax of America Inc has 22 FDA actions in our database, including 6 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2449-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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