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 10
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Code information
Serial Numbers: 124703 139012 139023
Distribution pattern
US Nationwide Distribution
device · product 2 of 10
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Code information
Serial Numbers: Serial 150002 150017 125700 150005 150023 150009 150015 150003 Expanded Recall 11/15/21: 147120 147119 150011
Distribution pattern
US Nationwide Distribution
device · product 3 of 10
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Code information
Serial Numbers: 156011 156014
Distribution pattern
US Nationwide Distribution
device · product 5 of 10
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Code information
Serial Numbers: Serial 104007 104016 104005 104027 104012 104025 104013 132500 Expanded Recall 11/15/21: 104029 104020
Distribution pattern
US Nationwide Distribution
device · product 6 of 10
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Code information
Serial Numbers: 105500 105503 105501
Distribution pattern
US Nationwide Distribution
device · product 9 of 10
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Code information
Serial Numbers: Serial 111502 111503 111510 111507 111512 111508 111133 111504 111506 111513 111500 111501 111505 111514
Distribution pattern
US Nationwide Distribution
device · product 10 of 10
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
These labels are deterministic app interpretations, not FDA categories.
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
