—#101505

Product

Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206. The recalled GEMINI TF Big Bore system units equipped with software version: 3.6.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine 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 CT AC. 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: The recalled system units are identified as follows: Model Number: 882476, and Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206.

Why it was recalled

The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the these PET/CT system units.

Root cause (FDA determination)

Software design

Action the firm took

The firm , Philips Healthcare, issued a 'Customer Information Letter' dated August 9, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were not required to perform any action. A Philips' Field Service Engineer will visit each customer site and install the necessary software upgrade and Philips will track the progress of the software corrections as they take place. For customers in North America, if you need any further information or support concerning this update, please contact our Customer Care Solutions Center at 1-800-722-9377. Selection option 5 for "All Imaging Systems". Enter your site ID number. If you do not know your site ID, please hold and then select option 5 for "Nuclear Medicine" and finally select option 2 for "PET" support. In all other countries, the local Philips Healthcare office should be contacted at 440-483-3000.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.

Timeline

Recall initiated: 2011-05-31
Posted by FDA: 2011-09-13
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101505. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.