ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
This recall is currently active, issued August 8, 2023. It was issued by Siemens Medical Solutions Usa, Inc.
- Recall Initiated
- June 19, 2023
- Posted
- August 8, 2023
- Recall Number
- Z-2361-2023
- Quantity
- 10 units
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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
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, Poland, Qatar, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
Lot / Code Info
UDI-DI: 4056869149325 Serial Numbers: Serial 164840 164851 164854 164853 164855 164856 164833 164836 164845 164850
Root Cause
Process control
Action Taken
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 coil of all affected systems. 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. 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