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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling

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  Class 2 Device Recall Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling see related information
Date Initiated by Firm October 21, 2020
Create Date November 18, 2020
Recall Status1 Terminated 3 on May 05, 2021
Recall Number Z-0469-2021
Recall Event ID 86660
510(K)Number K181407  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: 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 Serial numbers 109762 111158 124344 111161 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact Meredith Adams
610-219-4834
Manufacturer Reason
for Recall		 Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.
FDA Determined
Cause 2		 Employee error
Action On October 21, 2020, the firm notified customers via Urgent Medical Device Correction letter. The letter informed customers of the hardware error, and that customers could continue to use their system but needed to follow their standard emergency procedures they had in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all affected users via Update Instruction AX018/20/S. The Siemens Service organization will exchange the affected printed circuit boards of the generator. This modification will bring the voltage back to the center of the tolerance range. Siemens' service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
Quantity in Commerce 26 distributed worldwide (4 in US)
Distribution Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and United Kingdom.
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.
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