ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona
Summary
The FDA issued a Class II for ARTIS is a family of dedicated angiography systems developed for single and bipl by Siemens AG/Siemens Healthcare GmbH. Reason: A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very ra.
Details
Source
Device Recall
External ID
Z-2241-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Lot/Code Info: ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325
Quantity Affected: 201 units in total
Reason for Recall
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
Distribution
Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
Type: FDA Mandated
Recall Initiated: 2024-06-26
Company
Forchheim, 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 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens AG/Siemens Healthcare GmbH has 3 FDA actions in our database, including 3 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 (Siemens AG/Siemens Healthcare GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens AG/Siemens Healthcare GmbH have FDA actions?
Siemens AG/Siemens Healthcare GmbH has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2241-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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