Recall Z-0473-2022— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0473-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-19

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2021-11-19. It names one FDA 510(k) clearance: K190578. Product: SOMATOM Definition AS-Computed tomography system Model 8098027. Reason: Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-11-19
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K190578 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM ConfidenceSiemens Medical Solutions USA, Inc.·cleared 2019-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SOMATOM Definition AS-Computed tomography system Model 8098027

Reason for recall

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

Data sourced from openFDA. This site is unofficial and independent of the FDA.