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 3
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed
Code information
Software version 4.9 and 4.10
Distribution pattern
Worldwide Distribution.
device · product 2 of 3
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed
Code information
Software version 4.9 and 4.10
Distribution pattern
Worldwide Distribution.
device · product 3 of 3
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed
