Recall Z-1469-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
| Date | Apr 27, 2023 (initiated Mar 21, 2023) |
| Status | Open, Classified |
| Reason | Examination room monitor connected with the hybrid cable may have a display issue and no image function is available |
| Root cause | Device Design |
| Action | 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 correc |
| Quantity | 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, Morocco, Nepal, Nigeria, Poland, Russia, Rwanda, Serbia, Slovenia, South Africa, Spain, Sudan, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133580 | ARTIS ONE Siemens Medical Solutions USA, Inc., Apr 28, 2014 |