|
Class 2 Device Recall Artis one |
|
Date Initiated by Firm |
January 12, 2018 |
Date Posted |
March 20, 2018 |
Recall Status1 |
Terminated 3 on August 28, 2018 |
Recall Number |
Z-1148-2018 |
Recall Event ID |
79538 |
510(K)Number |
K133580
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
Artis 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 Contact |
Meredith 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 |
Action |
Siemens 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 Commerce |
16 |
Distribution |
US Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and WA. |
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 SOLUTIONS USA, INC.
|
|
|
|