—#138780

Product

GEMINI TF Big Bore 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: K081135
Affected lot / code info: Model #882476 GEMINI TF Big Bore (453567473391); Serial Number: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9212, 9214, 9215, 9216, 9217, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226 & 9213.

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 #138780. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.