Z-0979-2014Class II

GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

Name: Z-0979-2014 GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2013-12-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-12-05 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH on 2013-12-05. FDA classified it as Class II and gives the reason as "The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study". 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-0979-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-05
Posted: 2014-02-12
Terminated: 2015-08-25
Recalling firm: Philips North America LLC
Product: GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.
Root cause tag: software
FDA root cause: Software design
Action: ON 12/5/2013 the firm sent Medical Device Correction Letters to their customers.
Quantity in commerce: 47 Units
Distribution: Product was shipped to the following states: AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT & WI. Product was also shipped to the following countries: Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia & Venezuela.
Product codes and lots: Model #882476, Serial #'s: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9228, 9229, 9231.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0979-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0979-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-12

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