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.
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device · product 1 of 1
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.
These labels are deterministic app interpretations, not FDA categories.
Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.
Code information
Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340