openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
Code information
Model # 10430603 Serial # 74192
Distribution pattern
Distributed to: MI, NY, CA, KY, ND, NE
device · product 2 of 3
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
Code information
Model # 10590000 Serial # 83398, and 83387
Distribution pattern
Distributed to: MI, NY, CA, KY, ND, NE
device · product 3 of 3
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
Code information
Model # 8098027 Serial # 96020, 96047, 96011, and 96029
