—#138767

Product

GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051170
Affected lot / code info: Model #882410 GEMINI GXL 16 Slice (453567971891); Serial Number: 4170 & 4147A.

Why it was recalled

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Root cause (FDA determination)

Software design

Action the firm took

On 7/6/2015 the firm sent Field Safety Notices to their customers.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

Timeline

Recall initiated: 2015-07-01
Posted by FDA: 2015-07-22
Terminated: 2018-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138767. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.