ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Mat
FDA device recall Z-1469-2023 · posted 2023-04-27 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
- Action taken
- Siemens issued a Urgent Medical Device Correction letter AX065/22/S on 3/21/23. Letter states reason for recall, health risk and action to take: has been performed. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Siemens will correct the hardware error via Update Instruction AX061/22/S. This measure will replace the current hybrid cable with a design improvement to enhance stability and quality of the signal transmission. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 4 units US
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia, Iraq, Japan, Malaysia
- Date initiated
- 2023-03-21
- Date posted
- 2023-04-27
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ONE (K133580) | Siemens Medical Solutions USA, Inc. | 2014-04-28 |