Recall Z-1497-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
| Date | Mar 19, 2021 |
| Status | Terminated |
| Reason | Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system. |
| Root cause | Software design |
| Action | On 3/19/2021, Siemens Healthineers, issued an "URGENT: MEDICAL DEVICE CORRECTION" notice via letter dated 3/192021 to customers informing them of a possible hazard to patients, operators, or other persons and equipment due to a software error which affects ARTIS icono /pheno systems with software VE20C. The customer are instructed to do the following: The user should be aware of the limited system functionality in backup mode and bypass fluoroscopy operating mode (see also Operator Manual, Chapter 6.7: System Operating Modes). In some rare cases, the automatic recovery phase may not be succ |
| Quantity | 133 systems |
| Distribution | Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL. |
| FDA record | Open on fda.gov |