Recall Z-1498-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
| Date | May 2, 2023 (initiated Feb 2, 2023) |
| Status | Open, Classified |
| Reason | If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Road |
| Root cause | Software design |
| Action | Siemens Healthineers issued to all users of ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM) a Customer Safety Advisory Notice to affected customers via AX041/22/S dated 2/3/23. Letter states reason for recall, health risk and action to take for addressing three potential software issues: Detection of wrong table movement direction; Adjust C-arm to Ref; Missing movement stop with multiple collision sensor activation. Siemens will correct the software error via Update Instructions AX040/22/S. Our service organization will contact you shortly to arrange a dat |
| Quantity | 141 units US |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163286 | ARTIS pheno Siemens Medical Solution USA, Inc., Mar 9, 2017 |