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.
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
These labels are deterministic app interpretations, not FDA categories.
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
Code information
UDI-DI: B228INTELEPACS0. Version/Dates of Distribution: PACS-5-6-1-R64 through R68/02 Jul 2025 - 10 Sep 2025, PACS-5-7-1-R42 through R47/26 June 2025 - 25 Sep 2025, PACS 5-8-1-R20 through R23/26 Jun 2025 - 25 Sep 2025, PACS-5-9-1-R1 through R3/30 Jun 2025 - 09 Sep 2025
Distribution pattern
US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
