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 5
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Code information
Model 781357: UDI-DI: 00884838088108; Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071; Model 782106: UDI-DI: 00884838098329; Serial Numbers: 46224 46225 46265 46269 46311; Model Number 782137: UDI-DI: 00884838108615; Serial Numbers: Included in Letter but No Devices Distributed in the US.
Distribution pattern
US Nationwide.
device · product 2 of 5
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Code information
Model 781358: UDI-DI: 00884838088115; Serial Numbers: 45002 45051 45075 45108 45133 45164 45243 45269 45337 45356 45010 45053 45086 45112 45147 45178 45245 45296 45338 45357 45011 45054 45087 45113 45150 45179 45247 45321 45343 45364 45024 45060 45089 45124 45152 45194 45252 45322 45353 45395 45027 45068 45099 45132 45161 45238 45263 45335 45355 45414 45026 45055 45082 45100 45235 45237 45264 45315 45398 45423 45032 45078 45092 45146 45236 45261 45277 45316 45399 45429 45035; Model Number 782107: UDI-DI: 00884838098336; Serial Numbers: 45563 45570; Model Number 782119: UDI-DI: 00884838104129; Serial Numbers: Included in Letter but No Devices Distributed in US Model Number 782136: UDI-DI: 00884838108608; Serial Numbers: Included in Letter but No Devices Distributed in US
Distribution pattern
US Nationwide.
device · product 3 of 5
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Code information
Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US.
