Z-0197-2016Class II

GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron...

Name: Z-0197-2016 GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2008-05-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-05-01 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed... on 2008-05-01. FDA classified it as Class II and gives the reason as "The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0197-2016
Classification: Class II
Status: Terminated
Initiated: 2008-05-01
Posted: 2015-11-02
Terminated: 2015-11-06
Recalling firm: Philips North America LLC
Product: GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
FDA root cause: Unknown/Undetermined by firm
Action: Philips field service personnel will conduct customer visits in order to inspect systems. For further questions please call (440) 483-7600.
Quantity in commerce: 264 units
Distribution: Worldwide Distribution - US Distribution to the states of : AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Canada, Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Luxembourg, Mexico, Netherlands, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and UK.
Product codes and lots: Model Name Model NUmber and serial number GEMINI Dual 4535 679 00891 G097, G119, 101-103, 105-107, 109-117, 119-127, 131-144, 146-164, 1025, 2003506, 2003507, 1Z9Z591, 2Z9Z591, 3Z9Z591, 4Z9Z591, GY9Z591, HY9Z591, JY9Z591 GEMINI 16 Power 4535 679 58961 1002, 1004-1008, 1010-1015, 1017-1028, 1030-1034, 1035R, 1036A, 1037-1046, 101R, 1023a, G098, MNM4411 GEMINI GXL (6, 10, 16, and 16 Mobile) 4535 679 75691, 4535 679 81871, 4535 679 76581, 4535 679 71891 4001, 4003-4040, 4042-4089, 4091-4123, 4125-4127, 4129-4137, 4139-4143, 7011, 4097A, 4147a GEMINI TF 16 Slice (16, 64, 64 Mobile and 16 Base) 4535 679 83931, 4535 674 47551, 4535 679 94741, 4535 674 41711 7001, 7003-7006, 7008, 7009, 7013-7017, 7022, 7024, 7025, 7027, 7028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0197-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0197-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-02

Product code JAK

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)