Summary
The FDA issued a Class II for Revolution CT, Revolution CT ES by GE Healthcare, LLC. Reason: The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being i.
Details
Source
Device Recall
External ID
Z-0816-2022
Action Date
2022-04-13
Status
Ongoing
Category
device
Product Description
Revolution CT, Revolution CT ES
Lot/Code Info: Revolution CT, Revolution CT ES
Quantity Affected: 273 (51 US; 222 OUS) in total
Reason for Recall
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
Distribution
Worldwide - US Nationwide distribution.
Type: FDA Mandated
Recall Initiated: 2021-06-30
Company
Waukesha, WI
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 149 device recalls issued in the same week, part of 413 device-related FDA actions this month.
GE Healthcare, LLC has 104 FDA actions in our database, including 104 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 (GE Healthcare, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Healthcare, LLC have FDA actions?
GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0816-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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