—#138771

Product

GEMINI TF 64 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: K052640
Affected lot / code info: Model #882471 GEMINI TF 64 Slice (453567994741); Serial Number: 7007, 7012, 7042, 7055, 7083, 7103, 7116, 7126, 7132, 7158, 7160, 7164, 7169, 7175, 7179, 7218, 7221, 7229, 7245, 7255, 7256 & 7552.

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 #138771. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.