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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS icono and ARTIS pheno

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  Class 2 Device Recall ARTIS icono and ARTIS pheno see related information
Date Initiated by Firm March 19, 2021
Create Date April 26, 2021
Recall Status1 Terminated 3 on November 09, 2021
Recall Number Z-1497-2021
Recall Event ID 87620
510(K)Number K193326  K201156  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Interventional Fluoroscopic X-Ray System
ARTIS icono biplane- 11327600
ARTIS icono floor- 11327700
ARTIS pheno- 10849000

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.
Code Information Software VE20C serial #s 180062 170319 180317 180072 180060 180048 180083 180315 170305 180080 180301 180305 180330 170307 180040 180333 170309 170310 170304 180316 180334 170025 180047 180085 180331 180321 180309 170312 180323 164703 170303 180329 180015 180014 180037 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact Meredith Adams
610-448-6478
Manufacturer Reason
for Recall		 Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
FDA Determined
Cause 2		 Software design
Action On 3/19/2021, Siemens Healthineers, issued an "URGENT: MEDICAL DEVICE CORRECTION" notice via letter dated 3/192021 to customers informing them of a possible hazard to patients, operators, or other persons and equipment due to a software error which affects ARTIS icono /pheno systems with software VE20C. The customer are instructed to do the following: The user should be aware of the limited system functionality in backup mode and bypass fluoroscopy operating mode (see also Operator Manual, Chapter 6.7: System Operating Modes). In some rare cases, the automatic recovery phase may not be successful within 4 minutes. If necessary, it may be continued with manual recovery according to the Operator Manual instructions, Chapter 3.13: Recovering functions in case of system failures. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. Promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Please ensure that this safety advisory is retained in your product related records appropriately. In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. Siemens will update the affected software to prevent this non-conformity from reoccurring via Update Instruction AX023/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. If you have any further questions, contact the Siemens Medical Solution USA, Inc., at 610-448-6478 or email: Meredith.adams@siemens-healthineers.com.
Quantity in Commerce 133 systems
Distribution Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solution USA, Inc.
510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solutions USA, Inc.
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