—#101749

Product

GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081135
Affected lot / code info: Catalogue #882476; Gantry S/N 9001-9023

Why it was recalled

Two non-safety related defects have been found on the Philips GEMINI TF Big Bore running version 3.6; if these defects were to recur, it could impact the performance or reliability of the system. Philips is issuing a software update to all Philips GEMINI TF Big Bore customers to correct these defects.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

Philips Medical Systems (Cleveland) Inc. sent an "GEMINI TF BIG BORE CPE CUSTOMER LETTER" dated October 20, 2011 to all affected customers. The letter describes the product, problem, and updates that are available to the customers. The letter provides additional information about acquisition workflows for SUV Calibrations and Validations. For support concerning this upgrade, contact the Customer Care Solutions Center at 1-800-722-9377.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of CO, LA, MD, MI, MO, MN, PA, TX, VA, VT and WI and the countries of Belgium, Germany, Italy, Saudi Arabia and Switzerland.

Timeline

Recall initiated: 2009-08-05
Posted by FDA: 2011-08-01
Terminated: 2012-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101749. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.