🔍 RecallPedia

Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Class I - Dangerous
🏥 Medical Devices Recalled: November 12, 2016 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    30041, 31001, 33084, 52000, 52004, 52007, 52008, 52010, 52012, 52013, 52014, 52015, 52018, 52019, 52020, 52021, 52022, 52024, 52025, 52026, 52027, 52029, 52030, 52031, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52039, 52040, 52041, 52042, 52043, 52044, 52045, 52046, 52047, 52048, 52050, 52052, 52053, 52054, 52055, 52056, 52057, 52058, 52059, 52061, 52063, 52064, 52065, 52067, 52068, 52069, 52070, 52071, 52072, 52074, 52075, 52076, 52077, 52078, 52079, 52081, 132164, 132465, 310001, 310002, 310003, 310009, 310017, 310019, 310022, 310023, 310026, 310032, 310039, 310042, 310052, 310054, 310055, 310059, 310064, 310069, 310070, 310071, 310081, 310087, 310088, 310090, 310096, 310098, 310105, 310107, 310111, 310113, 310116, 310119, 310121, 310125, 310129, 310133, 310134, 310135, 310141, 310143, 310149, 310150, 310151, 310157, 310159, 310160, 310170, 310203, 310204, 310205, 310206, 310207, 310208, 310209, 310210, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310235, 310236, 310237, 310238, 310239, 310240, 310241, 310242, 310243, 310245, 310246, 310247, 310248, 310249, 310250, 310252, 310253, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310279, 310280, 310281, 310282, 310283, 310284, 310285, 310286, 310287, 310288, 310289, 310290, 310291, 310292, 310293, 310294, 310295, 310296, 310297, 310299, 310300, 310301, 310303, 310304, 310308, 310311, 310312, 310313, 310315, 310316, 310318, 310320, 310328, 310329, 310333, 310336, 310337, 310341, 310342, 310343, 333002, 333005, 333009, 333010, 333014, 333015, 333018, 333019, 333021, 333030, 333031, 333037, 333041, 333042, 333043, 333044, 333045, 333046, 333048, 333049, 333050, 333051, 333052, 333053, 333054, 333055, 333056, 333059, 333060, 333061, 333062, 333063, 333064, 333065, 333066, 333067, 333068, 333069, 333070, 333071, 333072, 333073, 333074, 333075, 333076, 333077, 333078, 333079, 333080, 333081, 333082, 333083, 333085, 333086, 333087, 333088, 333089, 333090, 333091, 333092, 333093, 333094, 333095, 333096, 333097, 333098, 333099, 333100, 333101, 333102, 333103, 333104, 333105, 333106, 333107, 333108, 333109, 333110, 333111, 333112, 333113, 333114, 333115, 333116, 333117, 333118, 333119, 333121, 333122, 333123, 333124, 333125, 333128, 333129, 333133, 333134, 333135, 333136, and 333145.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Medical Systems (Cleveland) Inc
Reason for Recall:
Software error due to the filament on timer
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Product Codes/Lot Numbers:

30041, 31001, 33084, 52000, 52004, 52007, 52008, 52010, 52012, 52013, 52014, 52015, 52018, 52019, 52020, 52021, 52022, 52024, 52025, 52026, 52027, 52029, 52030, 52031, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52039, 52040, 52041, 52042, 52043, 52044, 52045, 52046, 52047, 52048, 52050, 52052, 52053, 52054, 52055, 52056, 52057, 52058, 52059, 52061, 52063, 52064, 52065, 52067, 52068, 52069, 52070, 52071, 52072, 52074, 52075, 52076, 52077, 52078, 52079, 52081, 132164, 132465, 310001, 310002, 310003, 310009, 310017, 310019, 310022, 310023, 310026, 310032, 310039, 310042, 310052, 310054, 310055, 310059, 310064, 310069, 310070, 310071, 310081, 310087, 310088, 310090, 310096, 310098, 310105, 310107, 310111, 310113, 310116, 310119, 310121, 310125, 310129, 310133, 310134, 310135, 310141, 310143, 310149, 310150, 310151, 310157, 310159, 310160, 310170, 310203, 310204, 310205, 310206, 310207, 310208, 310209, 310210, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310235, 310236, 310237, 310238, 310239, 310240, 310241, 310242, 310243, 310245, 310246, 310247, 310248, 310249, 310250, 310252, 310253, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310279, 310280, 310281, 310282, 310283, 310284, 310285, 310286, 310287, 310288, 310289, 310290, 310291, 310292, 310293, 310294, 310295, 310296, 310297, 310299, 310300, 310301, 310303, 310304, 310308, 310311, 310312, 310313, 310315, 310316, 310318, 310320, 310328, 310329, 310333, 310336, 310337, 310341, 310342, 310343, 333002, 333005, 333009, 333010, 333014, 333015, 333018, 333019, 333021, 333030, 333031, 333037, 333041, 333042, 333043, 333044, 333045, 333046, 333048, 333049, 333050, 333051, 333052, 333053, 333054, 333055, 333056, 333059, 333060, 333061, 333062, 333063, 333064, 333065, 333066, 333067, 333068, 333069, 333070, 333071, 333072, 333073, 333074, 333075, 333076, 333077, 333078, 333079, 333080, 333081, 333082, 333083, 333085, 333086, 333087, 333088, 333089, 333090, 333091, 333092, 333093, 333094, 333095, 333096, 333097, 333098, 333099, 333100, 333101, 333102, 333103, 333104, 333105, 333106, 333107, 333108, 333109, 333110, 333111, 333112, 333113, 333114, 333115, 333116, 333117, 333118, 333119, 333121, 333122, 333123, 333124, 333125, 333128, 333129, 333133, 333134, 333135, 333136, and 333145.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0695-2017

Related Recalls

Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

Aug 5, 2025 Other Medical Devices Nationwide View Details →