FDA (Devices) recall action 83203
The FDA (Devices) publishes a recall like this one as 23 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 23 pages.
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
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 is recalling 39 AXIOM Artis dFA units because a power supply issue may cause generator failure, preventing X-ray production during procedures.
Siemens is recalling four AXIOM Artis FA units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Siemens is recalling 178 AXIOM Artis dTA units due to a power supply issue that may prevent X-ray generation during procedures.
Siemens Medical Solutions is recalling three Artis zee biplane MN units due to a power supply tolerance issue that may prevent X-ray generation during procedures.
Siemens is recalling 19 AXIOM Artis dFC units because a power supply tolerance issue may cause generator failure, preventing X-ray procedures.
Siemens Medical Solutions is recalling 117 Artis zeego units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
Siemens is recalling five AXIOM Artis FC units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Siemens is recalling 24 AXIOM Artis MP units because a power supply tolerance issue may cause generator failure, preventing X-ray procedures.
Siemens is recalling five AXIOM Artis TA units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
Siemens Medical Solutions is recalling 170 Artis zee floor units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Siemens is recalling seven AXIOM Artis BA X-ray systems because a power supply defect may cause the generator to fail, preventing X-ray imaging.
Siemens is recalling 98 AXIOM Artis dTC units because a power supply tolerance issue may cause generator failure, preventing X-ray imaging.
Siemens is recalling 23 Artis zee floor MN units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Siemens is recalling 53 AXIOM Artis dBC units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
Siemens is recalling 85 AXIOM Artis dBA units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.
Siemens is recalling 32 AXIOM Artis dMP units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.
Siemens Medical Solutions is recalling 428 Artis zee ceiling units due to a power supply tolerance issue that may cause generator failure and prevent X-ray production.
Siemens is recalling 268 Artis zee biplanes because a power supply tolerance issue may cause generator failure, preventing X-ray production during procedures.
Siemens is recalling 89 Artis zee multi units because a power supply issue may cause the X-ray generator to fail during procedures.
Siemens is recalling six AXIOM Artis BC units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.
Siemens is recalling one AXIOM Artis dBC X-ray system because a power supply defect may prevent X-ray generation during procedures.
Siemens is recalling one AXIOM Artis TC unit due to a power supply tolerance issue that may cause X-ray generation failure during procedures.
Siemens is recalling 148 AXIOM Artis dFC units because a power supply defect may cause the X-ray generator to fail during procedures.