INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Summary
The FDA issued a Class II for INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONS by Canon Medical System, USA, INC.. Reason: The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement..
Details
Source
Device Recall
External ID
Z-2392-2023
Action Date
2023-08-16
Status
Ongoing
Category
device
Product Description
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Lot/Code Info: UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003
Quantity Affected: 12
Reason for Recall
The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.
Distribution
US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-22
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 208 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-2392-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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