Recall Z-2361-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
| Date | Aug 8, 2023 (initiated Jun 19, 2023) |
| Status | Open, Classified |
| Reason | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system |
| Root cause | Process control |
| Action | Siemens issued Urgent: Medical Device Correction to all users of ARTIS icono/ ARTIS pheno systems with a specific Polydoros ACX power generator on 6/19/23. Letter states reason for recall, health risk and action to take: It is strongly recommended to establish 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 for the safety of the patient. Siemens will correct the hardware error via Update Instruction AX008/23/S. This measure will correct the Polydoros ACX reactor |
| Quantity | 10 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Latvia, Luxembourg, Macedonia, Mexico, Monaco, Netherlands, New Zealand, Norway |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220409 | ARTIS pheno (VE21) System Siemens Medical Solutions USA, Inc., Jun 29, 2022 |