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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Artis one systems

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 Class 2 Device Recall Siemens Artis one systemssee related information
Date Initiated by FirmSeptember 21, 2020
Create DateOctober 27, 2020
Recall Status1 Terminated 3 on August 03, 2021
Recall NumberZ-0298-2021
Recall Event ID 86512
510(K)NumberK133580 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductSiemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
Code Information Serial Numbers: 82010 82038 82039 82040 82044 82054 82065 82066 82070 82102 82105 82108 82109 82205 82213 82217 82267 82308 82354 82355 82378 82383  
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information ContactSAME
610-219-4834
Manufacturer Reason
for Recall		Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
FDA Determined
Cause 2		Component design/selection
ActionSiemens issued Urgent Medical Device Correction notification letter dated 9/22/20 via AX053/20/S stating reason for recall, health risk and action to take: Siemens will correct the error with a hardware replacement of the Display Port transceiver via Update Instruction AX052/20/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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document.
Quantity in Commerce22 units
DistributionUS Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OWB
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