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Recall Observatory FDA recall evidence

Device product

Ingenuity Core Computed Tomography X-ray system

Z-0547-2016

October 29, 2015

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 72684
Status
Terminated
Classification
Class II
Quantity
135 Units
Official record key
device-enforcement:Z-0547-2016

Official wording

Reason: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

Code information: Model No. 728321; S/N: 52007, 52008, 52010, 52013, 52014, 52015, 52018, 52019, 52020, 52021, 52024, 52027, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52040, 52041, 52042, 52045, 52046, 52047, 52048, 52051, 52053, 52055, 52057, 52058, 52060, 52064, 52065, 52067, 52068, 52069, 52070, 52075, 52078, 310017, 310026, 310039, 310042, 310052, 310055, 310059, 310064, 310069, 310071, 310081, 310088, 310098, 310111, 310113, 310119, 310121, 310133, 310143, 310144, 310149, 310151, 310157, 310159, 310160, 310204, 310205, 310206, 310208, 310209, 310210, 310211, 310212, 310213, 310215, 310216, 310217, 310219, 310220, 310223, 310224, 310225, 310226, 310228, 310231, 333002, 333009, 333014, 333015, 333030, 333031, 333037, 333042, 333043, 333044, 333046, 333048, 333049, 333050, 333052, 333053, 333054, 333055, 333056, 333058, 333059, 333060, 333061, 333062, 333063, 333065, 333066, 333067, 333069, 333070, 333072, 333073, 333074, 333075, 333076, 333077, 333078, 333079, 333080, 333081, 333082, 333086, 333087, 333090, 333091, 333093, 333101, 333110 & 333112.

Distribution pattern: Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software (versions preceding 4.1.2) without buying the helical perfusion license key could