FDA (Devices) recall action 80286
The FDA (Devices) publishes a recall like this one as 12 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 12 pages.
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
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 Artis zee MP systems because the display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.
Siemens is recalling two Artis zee biplane MN systems because the large display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.
Siemens Medical Solutions is recalling two Artis Q.zen biplane systems because the display may fail to show images after power save mode, potentially requiring treatment cancellation or patient transfer.
Siemens Medical Solutions is recalling five Artis Q ceiling units because the display may fail to show an image after exiting power save mode, potentially requiring treatment cancellation.
Siemens Medical Solutions is recalling 56 Artis zeego systems because the display may fail to show images after power save mode, potentially requiring procedure cancellation.
Siemens is recalling 68 Artis zee biplane systems because the large display may remain black after exiting power save mode, potentially requiring treatment cancellation or patient transfer.
Siemens is recalling Artis zee floor MN systems because the display may fail to show images after power save mode, potentially requiring procedure cancellation.
Siemens is recalling 14 Artis zee floor systems because the display may fail to show images after power save mode, potentially requiring treatment cancellation.
Siemens is recalling 73 Artis zee ceiling units because the display may fail to show images after power save mode, potentially requiring procedure cancellation.
Siemens is recalling Artis Q.zen floor units because the display may fail to show images after power save mode, potentially requiring procedure cancellation or patient transfer.
Siemens is recalling four Artis Q.zeego X-ray systems because the display may remain black after power save mode, preventing normal operation and requiring procedure cancellation or patient transfer.
Siemens is recalling five Artis Q biplanes because the display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.