INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Summary
The FDA issued a Class II for INFX-8000V. For radiographic and fluoroscopic studies and intervention. by Canon Medical System, USA, INC.. Reason: The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy..
Details
Source
Device Recall
External ID
Z-1666-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Lot/Code Info: Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
Quantity Affected: 16 systems
Reason for Recall
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2022-01-31
Company
Tustin, CA
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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Canon Medical System, USA, INC. has 25 FDA actions in our database, including 25 recalls.
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 (Canon Medical System, USA, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Canon Medical System, USA, INC. have FDA actions?
Canon Medical System, USA, INC. has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1666-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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