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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis Zee

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  Class 2 Device Recall Axiom Artis Zee see related information
Date Initiated by Firm August 22, 2008
Date Posted November 04, 2008
Recall Status1 Terminated 3 on September 23, 2009
Recall Number Z-0194-2009
Recall Event ID 49529
510(K)Number K073290  
Product Classification Angiographic X-ray System - Product Code IZI
Product Axiom Artis Zee. Angiographic X-ray System.
Code Information Serial numbers: 135000, 135102, 135109, 135111, 135112, 135114, 135117, 135120, 135122, 135124, 135125, 135128, 135129, 135133, 135137, 135143, 135144, 135145, 135148, 135151, 135152, 135157, 135169, 140100, 140101, 140102, 146103, 146104, 146107, 146111, 146113, 146116, 146118, 146119, 146121, 146122, 146123, 146124, 146130, 146137, 146138, 146139, 146140, 146144, 146147, 146149, 146150, 146154, 146155, 146152, 146156, 146158, 146159, 146161, 146164, 146166, 146167, 146168, 146170, 146171, 146173, 153101, 153102, 153106, 153107, 153109, 153110, 153111, 153112, 153113, 153115, 153117, 153119, 153120, 153122, 153124, 153125, 153128, 153129, 153130, 153131, 153132, 153134, 153135, 153139, 153141, 153145, 153147, 153148, 153150, 153153, 153154, 153155, 153156, 153157, 153159, 153160, 153161, 153164, 153166, 153167, 153169, 153171, 153172, and 153173.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact
801-595-0700
Manufacturer Reason
for Recall		 Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table.
FDA Determined
Cause 2		 Labeling design
Action The recalling firm issued a Customer Safety Advisory Notice dated 7/04/08 (including an Addendum to the Operators Manual) which alerts the operator of possible injury to patients if they are not properly secured to the table during examinations and describes the recommended fastening procedures required to properly secure the patient to the table. For questions or additional information, contact Siemens Medical Solutions, Inc. at 610-448-4634.
Quantity in Commerce 108 units
Distribution Nationwide Distribution.
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 = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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