Z-1337-2020 Class II Terminated
FDA device recall Z-1337-2020 was initiated by Siemens Medical Solutions USA, Inc on January 8, 2020 and is designated Class II. Reason for recall: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. The recall status is terminated (terminated June 21, 2022). Affected quantity: 46.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- January 8, 2020
- Termination Date
- June 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46
Product Description
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF 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.
Reason for Recall
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Distribution Pattern
US Nationwide distribution.
Code Information
Serial Numbers 5043 5085 5825 5234 5862 5751 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962