FDA (Devices) recall action 73593
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.
Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens Medical Solutions USA is recalling 1,096 SOMATOM Definition CT systems due to software bugs that may cause scan aborts, re-scans, or accidental radiation.
Siemens is recalling 1,096 SOMATOM Definition AS CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.
Siemens Medical Solutions is recalling 1,096 CT systems due to software bugs that may cause scan aborts, rescans, or accidental x-radiation.
Siemens Medical Solutions is recalling 1,096 CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.