Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Serial Numbers: 7501, 7503, 7507,

FDA device recall Z-3199-2011 · posted 2011-09-13 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the these PET/CT system units.

Action taken

The firm , Philips Healthcare, issued a 'Customer Information Letter' dated August 9, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were not required to perform any action. A Philips' Field Service Engineer will visit each customer site and install the necessary software upgrade and Philips will track the progress of the software corrections as they take place. For customers in North America, if you need any further information or support concerning this update, please contact our Customer Care Solutions Center at 1-800-722-9377. Selection option 5 for "All Imaging Systems". Enter your site ID number. If you do not know your site ID, please hold and then select option 5 for "Nuclear Medicine" and finally select option 2 for "PET" support. In all other countries, the local Philips Healthcare office should be contacted at 440-483-3000.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

7 units were distributed.

Distribution

Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.

Date initiated

2011-05-31

Date posted

2011-09-13

Date terminated

2013-02-22

Location

Cleveland, OH

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