Recalls / —

—#142085

Product

Ingenuity Core Computed Tomography X-ray system

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K033326

Affected lot / code info

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.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

On 10/30/2015 the firm sent Customer Information letters to their Consignees.

Recalling firm

Firm

Philips Medical Systems (Cleveland) Inc

Address

595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

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.

Timeline

Recall initiated

2015-10-29

Posted by FDA

2015-12-24

Terminated

2018-06-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #142085. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.