Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Summary
The FDA issued a Class II for Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A by Canon Medical System, USA, INC.. Reason: A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automat.
Details
Source
Device Recall
External ID
Z-0142-2022
Action Date
2021-10-27
Status
Terminated
Category
device
Product Description
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Lot/Code Info: Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
Quantity Affected: 3 units
Reason for Recall
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
Distribution
US Nationwide distribution in the states of NV, AR MN.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-11-11
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 158 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-0142-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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