| Class 2 Device Recall Artis Q | |
Date Initiated by Firm | April 09, 2019 |
Create Date | May 15, 2019 |
Recall Status1 |
Terminated 3 on April 23, 2020 |
Recall Number | Z-1342-2019 |
Recall Event ID |
82730 |
510(K)Number | K123529 |
Product Classification |
System, x-ray, angiographic - Product Code IZI
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Product | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems 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 AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis. |
Code Information |
Serial Number 105121 105122 105123 105124 105125 111129 111130 111127 111106 111128 123245 123246 123240 123239 123244 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | 610-219-4834 |
Manufacturer Reason for Recall | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
FDA Determined Cause 2 | Software design |
Action | On April 9, 2019, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that ARTIS systems equipped with certain motor control units may encounter with hardware failure, and planned procedures may need to be terminated and performed on an alternative x-ray system.
The firm stated their service organization would contact customers shortly to arrange a date to perform a software update to correct the issue. For an earlier appointment or if you have any questions, you may contact the firm at 1-800-888-7436.
Customers were asked to promptly notify and instruct all staff at the organization who need to be aware of the notice. Additionally, if you further distributed the product, please identify your customers and notify them at once of this recall. |
Quantity in Commerce | 459 (116 US) |
Distribution | Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN,
MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries. |
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 = IZI
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