ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Summary
The FDA issued a Class II for ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328 by Siemens Medical Solutions USA, Inc. Reason: Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the s.
Details
Source
Device Recall
External ID
Z-0523-2024
Action Date
2023-12-20
Status
Ongoing
Category
device
Product Description
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Lot/Code Info: UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
Quantity Affected: 38 worldwide, 11 US
Reason for Recall
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
Distribution
US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-17
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 238 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-0523-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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