Recall Z-0707-2018
Siemens Medical Solutions USA, Inc · initiated June 6, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354
Codes / lots: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848353, 10848354, 10848355, 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, 7728392
Reason for recall
Potential for liquid entry
FDA-determined cause: Device Design
Action taken
On June 6, 2017, Siemens Healthineers distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via USPS Certified Mail. Siemens conducted a corrective field action in June 2015 to protect the Artis table against liquid entry at critical locations. However, even with this corrective action, if there are larger amounts of liquid on the table surface, they can still enter the table. Siemens Medical Solutions USA, Inc. will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment by calling 610-448-6461.
Details
- Recall number
- Z-0707-2018
- Initiated
- June 6, 2017
- Terminated
- May 16, 2019
- Product code
- IZI – System, X-Ray, Angiographic
- Distribution
- U.S. Nationwide
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0706-2018 Class II | Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355Potential for liquid entry | 06/06/2017Terminated |
| Z-0708-2018 Class II | Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755…Potential for liquid entry | 06/06/2017Terminated |