Date Initiated by Firm |
October 19, 2018 |
Create Date |
November 14, 2018 |
Recall Status1 |
Terminated 3 on April 27, 2020 |
Recall Number |
Z-0458-2019 |
Recall Event ID |
81514 |
510(K)Number |
K123529
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product |
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system
Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
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Code Information |
Serial Numbers: 121336 121368 121208 121371 121374 121209 121325 121357 121378 121369 121364 121314 121351 121354 121340 121365 121324 121216 121333 121381 121352 121355 121210 121215 121379 121366 121323 121370 121384 121332 121344 121309 121305 121342 121301 121315 121372 121321 121383 121312 121359 121322 121356 121319 121211 121375 121377 121361 121339 121310 121362 121316 121212 121313 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact |
SAME 610-219-4834
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Manufacturer Reason for Recall |
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
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FDA Determined Cause 2 |
Device Design |
Action |
Siemens issued on 10/19/18 an Urgent Medial Devoce Correction notification to via AX033/18/S advising users of the problem, health risk, steps to be taken.
Siemens has initiated screw connection exchange of the ceiling bearing via Update Instruction AXOSS/17 /S. |
Quantity in Commerce |
54 units |
Distribution |
US Nationwide Distribution |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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