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Siemens Medical Solutions USA, Inc recalls Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/
Recalled November 10, 2021 · FDA recall Z-0200-2022 · Siemens Medical Solutions USA
Hazard
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient · FDA Class II
Units
43 US
Sold at
US Nationwide distribution.
Description
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
Product
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →