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Terminated

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.

FDA Recall Z-0197-2016 · Posted 2015-11-02

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2008-05-01
Date Terminated2015-11-06
Product Quantity264 units

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.

Firm Action

Philips field service personnel will conduct customer visits in order to inspect systems. For further questions please call (440) 483-7600.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052640GEMINI RAPTORPhilips Medical Systems (Cleveland), Inc. · 2005-10-07K051170GEMINI GXLPhilips Medical Systems (Cleveland), Inc. · 2005-05-23K032036GEMINI 16Philips Medical Systems (Cleveland), Inc. · 2003-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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