Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Summary
The FDA issued a Class II for Artis icono floor with software VE20C-diagnostic imaging angiography system Mod by Siemens Medical Solutions USA, Inc. Reason: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement af.
Details
Source
Device Recall
External ID
Z-0517-2022
Action Date
2022-02-02
Status
Terminated
Category
device
Product Description
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Lot/Code Info: Serial Numbers: 170319 170026 170343 170305 170307 170331 170309 170310 170023 170304 170328 170334 170336 170025 170346 170051 170333 170332 170312 170027 170303 170322 170053 UDI: 04056869149325
Quantity Affected: 23 units
Reason for Recall
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-12
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 97 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-0517-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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