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Class 2 Device Recall Artis Icono |
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Date Initiated by Firm |
May 20, 2022 |
Create Date |
July 06, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1342-2022 |
Recall Event ID |
90401 |
510(K)Number |
K193326
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product |
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 |
Code Information |
UDI-DI: 04056869063317
Serial Numbers:
180062
180054
180019
180065
180056
180057
180041
180317
180034
180072
180349
180367
180382
180060
180399
180337
180070
180048
180083
180369
180370
180371
180372
180345
180315
180343
180080
180301
180305
180067
180330
180040
180379
180386
180360
180333
180029
180352
180336
180407
180400
180397
180316
180068
180363
180084
180334
180018
180350
180376
180354
180046
180047
180335
180085
180035
180339
180357
180358
180361
180362
180081
180331
180381
180021
180342
180321
180309
180356
180378
180393
180368
180341
180323
180329
180043
180049
180377
180077
180086
180053
180055
180015
180014
180066
180082
180037
180373
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Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact |
Meredith Adams 610-448-6478
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Manufacturer Reason for Recall |
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
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FDA Determined Cause 2 |
Process control |
Action |
On May 20, 2022, the firm sent Urgent Medical Device Correction letters to affected customers. Customers were informed that in the event this issue occurs, the system will switch to Bypass fluoroscopy mode. In Bypass fluoroscopy mode a limited imaging functionality (non-subtracted, continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available.
This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient.
Customer Instructions:
In the event you recognize a high squeaking scratching loud noise out of one of the system cabinets, please contact your service partner for immediate action. It is recommended to avoid performing any critical interventions on the system.
Due to the possible risk of electrical shock to the technician, please ensure that your service partner (if not Siemens Healthineers) first contacts Siemens Healthineers' service organization before starting any corrective actions.
The firm will replace the affected parts. The service organization will contact customers to arrange a date to perform the corrective action. To schedule an earlier appointment, contact the firm at 1-800-888-7436. |
Quantity in Commerce |
195 worldwide, 88 US |
Distribution |
Domestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Japan, Kazakhstan, Netherlands, New Zealand, Norway, Oman, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.
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Total Product Life Cycle |
TPLC Device Report
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = Siemens Medical Solutions USA, Inc.
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