Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815
- Recall Initiated
- September 24, 2021
- Recall Number
- Z-0200-2022
- Quantity
- 43 US
- Firm Location
- Malvern, PA
Reason for Recall
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
Distribution
US Nationwide distribution.
Lot / Code Info
Artis zeego systems with Artis patient table and AppSW VD20C/VD20N
Root Cause
Software design
Action Taken
Siemens Healthineers issued Urgent Medical Device Correction Letter (AX059/21/S) dated 9/24/21. Letter states reason for recall, health risk and action to take: To avoid possible incorrect patient treatment, Siemens recommends a working position with 0 degree table rotation be used if intraoperative 3D images are required for subsequent steps (e.g., image superimposition, C-arm positioning, laser cross). If it should still be necessary to use a table rotation other than 0 degrees for intraoperative 3D images, please verify the C-arm position, needle position and image superimposition, by means of fluoroscopy. Siemens will provide a software update for all affected systems in which the system calculates table rotations and 3D reconstructions correctly. This corrective action will be distributed via Update Instruction AX058/21/S. 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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. 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.