Z-3200-2011

Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502...

Name: Z-3200-2011 Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-05-31
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-05-31 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled... on 2011-05-31. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3200-2011
Status: Terminated
Initiated: 2011-05-31
Posted: 2011-09-13
Terminated: 2013-02-22
Recalling firm: Philips North America LLC
Product: Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 6 units
Distribution: 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.
Product codes and lots: The recalled system unit is identified as follows: Model Number: 882471 and Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164.

Product code JAK

K052640Class IIGemini RaptorPhilips Medical Systems (Cleveland), Inc. / cleared 2005-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)