Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedur
Summary
The FDA issued a Class II for Artis icono biplane -angiography systems developed for single and biplane diagno by Siemens Medical Solutions USA, Inc. Reason: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cau.
Details
Source
Device Recall
External ID
Z-1245-2022
Action Date
2022-06-15
Status
Ongoing
Category
device
Product Description
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Lot/Code Info: UDI-DI: 04056869063317 Serial Number: 180062 180054 180019 180065 180056 180057 180041 180317 180034 180072 180060 180070 180048 180083 180315 180080 180301 180305 180067 180330 180040 180333 180029 180336 180316 180084 180334 180018 180046 180047 180335 180085 180035 180081 180331 180021 180321 180309 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037
Quantity Affected: 51 units
Reason for Recall
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-11
Company
Malvern, PA
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 178 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 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 (Siemens Medical Solutions 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 Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1245-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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