Z-2037-2014Class II

GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging...

Name: Z-2037-2014 GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2014-06-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-06-18 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that... on 2014-06-18. FDA classified it as Class II and gives the reason as "When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the...". 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-2037-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-18
Posted: 2014-07-10
Terminated: 2015-09-16
Recalling firm: Philips North America LLC
Product: GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occurs randomly.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare is informing the consignee of this issue through a Field Safety Notice (FSN) 88200487-488. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to install the software update.
Quantity in commerce: 33
Distribution: Distributed in the states of CA, CO, IL, OK, OR and WI.
Product codes and lots: GEMINI TF PET/CT16: 882470 7019,7039,7099,7588,7593,7598,7599,7600,7604,7605,7596M GEMINI TF PET/CT 64: 882471 7027,7044,7146,7153,7178,7182,7188,7578,7579,7585,7587,7589,7592,7594,7595,7602, 7603, 7606 GEMINI TF Big Bore: 882476 9019,9227,9232,9233

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2037-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2037-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-10

Product code KPS

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)