—#104992

Product

Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are 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 GEMINI TF 16 system units are identified as follows: Model Number: 882470 and Model #882473, Serial Numbers: 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7244, and 7237.

Why it was recalled

In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, 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

Philips Healthcare sent a "CPE CUSTOMER LETTER" dated October 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Additionally, device operation information is provided to customers. A Philips Field Service Engineer will be visiting each customer site to install the necessary software upgrades. Contact the Customer Care Solutions Center at 1-800-722-9377 for questions concerning this notice.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including the states of CO, LA, MD, MI, MN, PA, TX, VA, VT, and WI.

Timeline

Recall initiated: 2011-04-25
Posted by FDA: 2011-12-01
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104992. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.