Z-2915-2011

GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI...

Name: Z-2915-2011 GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2009-08-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-08-05 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2009-08-05. The reason FDA records is "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...". 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-2915-2011
Status: Terminated
Initiated: 2009-08-05
Posted: 2011-08-01
Terminated: 2012-09-21
Recalling firm: Philips North America LLC
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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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 tag: software
FDA root cause: Software design (manufacturing process)
Action: 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.
Quantity in commerce: 23 units
Distribution: 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.
Product codes and lots: Catalogue #882476; Gantry S/N 9001-9023

Product code KPS

K081135Class IIGemini CondorPhilips Medical Systems (Cleveland), Inc. / cleared 2008-04-29

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)