medical Class II Updated 2018-07-04

Siemens Medical Solutions USA, Inc recalls Artis zee ceiling, Material no. 10094137, for angiography an

Recalled Product

Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 147763 147573 147608 147760 147636 147630 147208 147514 147165 147558 147304 146946 147585 147553 147645 147087 147203 147601 147659 147675 147516 147700 147745 147681 147795 147773 147789 147541 147577 147029 147625 147635 146152 147660 147753 147083 146861 147561 147771 147657 147364 147775 147790 147781 147734 146896 147559 147620 147287 147749 147633 147737 147621 147250 147253 147252 147251 147717 147778 147643 147670 147234 147557 147661 147235 147716 147739 147743 147752 147528 147687 146867 147186

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