| Class 2 Device Recall Axiom Artis Zee | |
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
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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
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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 |
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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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