Summary
The FDA issued a Class II for Phoenix mKDR, digital mobile diagnostic x-ray system by SEDECAL SA. Reason: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems..
Details
Source
Device Recall
External ID
Z-1202-2023
Action Date
2023-03-08
Status
Ongoing
Category
device
Product Description
Phoenix mKDR, digital mobile diagnostic x-ray system
Lot/Code Info: UDI/DI 08436046003002, Serial Numbers: PH00092, PH00093, PH00094, PH00095, PH00097, PH00098, PH00099, PH00100, PH00110, PH00111, PH00112, PH00113, PH00114, PH00115, PH00116, PH00117, PH00118, PH00135, PH00136, PH00137, PH00138, PH00139, PH00140, PH00141, PH00142, PH00143, PH00144, PH00161, PH00162, PH00163, PH00164, PH00165, PH00166, PH00167, PH00168, PH00169, PH00176, PH00177, PH00178, PH00179, PH00180, PH00181, PH00185, PH00186, PH00187, PH00188, PH00189, PH00190, PH00191, PH00192, PH00010, PH00090, PH00091
Quantity Affected: 53 units
Reason for Recall
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Distribution
US, Argentina, Panama
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-06
Company
Algete, N/A
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 403 device-related FDA actions this month.
SEDECAL SA has 57 FDA actions in our database, including 53 recalls and 4 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 (SEDECAL SA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SEDECAL SA have FDA actions?
SEDECAL SA has 57 FDA actions in our database, including 53 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1202-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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