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 4
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
These labels are deterministic app interpretations, not FDA categories.
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
These labels are deterministic app interpretations, not FDA categories.
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
These labels are deterministic app interpretations, not FDA categories.
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
These labels are deterministic app interpretations, not FDA categories.
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
