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U.S. Department of Health and Human Services

Class 2 Device Recall Artis one

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 Class 2 Device Recall Artis onesee related information
Date Initiated by FirmJanuary 12, 2018
Date PostedMarch 20, 2018
Recall Status1 Terminated 3 on August 28, 2018
Recall NumberZ-1148-2018
Recall Event ID 79538
510(K)NumberK133580 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductArtis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include cardiac angiography, neuro-angiography, general angiography, rotational angiography; multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Code Information Serial numbers: 82044 82105 82070 82213 82054 82040 82038 82205 82065 82267 82108 82010 82039 82109 82102 82066 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMeredith Adams
610-448-6461
Manufacturer Reason
for Recall		Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
FDA Determined
Cause 2		Process control
ActionSiemens sent an Urgent - Medical Device Correction letter dated January 5, 2018. Siemens will conduct an inspection of all affected Artis tables and verify the correct positioning of the bolt as well as the snap rings. The letter recommends the consignees follow Please follow the standard emergency procedures they have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. The Siemens service organization will contact the consignees to arrange a date to perform the corrective action. For further questions, please call (610) 448-6461.
Quantity in Commerce16
DistributionUS Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and 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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