Date Initiated by Firm | November 30, 2020 |
Create Date | January 11, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0656-2021 |
Recall Event ID |
87026 |
510(K)Number | K181407 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product | Artis zee/ zeego & Artis Q/ Q.zen
Artis Pheno |
Code Information |
Model number: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Pheno- 10849000 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355
|
For Additional Information Contact | Meredith Adams 610-219-4834 |
Manufacturer Reason for Recall | When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits. |
FDA Determined Cause 2 | Software design |
Action | Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers via AX067/20/P on November 30, 2020. All modifications and repairs are provided to affected customers free of charge. |
Quantity in Commerce | 5602 |
Distribution | Worldwide-US Nationwide |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = OWB
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