Recall Z-1294-2022 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
| Date | Jun 27, 2022 (initiated Jun 10, 2022) |
| Status | Open, Classified |
| Reason | A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room. |
| Root cause | Process control |
| Action | Firm notified customers of the recall on June 10, 2022 via Urgent Medical Device Correction letters. The firm strongly recommends reinforcing appropriate emergency procedures until the corrective action has been performed. Please ensure that patient treatment can be continued in other ways if there is any possible danger to the safety of the patient. The firm will exchange the affected video transmission links. Their service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact the firm's service organization for an earlier appo |
| Quantity | 136 systems |
| Distribution | Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand T |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201156 | ARTIS pheno (VE2) Siemens Medical Solution USA, Inc., Jun 29, 2020 |