Recall Z-1332-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
| Date | Jan 8, 2020 |
| Status | Terminated |
| Reason | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function. |
| Root cause | Use error |
| Action | On January 8, 2020, the firm initiated the recall, notifying customers via Urgent Medical Device Correction letters. Customers were advised of the potential for a system collision due to incorrect use of the bypass key overriding the built-in collision control. The bypass key is intended to enable movement of an otherwise blocked system to avert immediate hazard, e.g. to recover a patient following device error or in case of emergency. It is not intended for permanent use. Customers were instructed to use the bypass key exclusively to avert an immediate hazard and immediately contact Siemens |
| Quantity | 475 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax Siemens Medi Cal Solutions, Inc., Apr 2, 2018 |