Z-1764-2020 Class II Terminated
FDA device recall Z-1764-2020 was initiated by Siemens Medical Solutions USA, Inc on April 6, 2020 and is designated Class II. Reason for recall: It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less… The recall status is terminated (terminated October 27, 2020). Affected quantity: 314 (wordwide).
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- April 6, 2020
- Termination Date
- October 27, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 314 (wordwide)
Product Description
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in sitting, standing, or supine positions.
Reason for Recall
It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.
Distribution Pattern
Worldwide Distribution
Code Information
serail number 1192