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Terminated

GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model #882471 Philips Medical Systems, Highland Heights, OH The device is 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-0805-2012 · Posted 2012-01-18

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2011-12-02
Date Terminated2013-02-22
Product Quantity197 units

Reason for Recall

Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed.

Firm Action

Philips Medical System sent a Urgent Medical Device Correction letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following are recommended actions: 1. Please ask your local Philips Service Engineer to ensure that the Auto Delete function is configured to run automatically. 2. Please share this information with all Philips GEMINI TF system operators at your site. 3. Retain this document with your system's instructions for Use Manual. For further information or support concerning this issue please contact your local Philips representative in the United States and Canada at 1-800-722-9377, and follow the recorded menu options to reach Customer Solutions Engineer; in all other countries please dial your local Philips Healthcare office.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including the states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NY, OH, OR, PA, PR, TN, TX, WA and WV. and the countries of: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Denmark, Egypt, France, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, Pakistan, Philippines, Poland, Russian Fed, Saudi, Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052640GEMINI RAPTORPhilips Medical Systems (Cleveland), Inc. · 2005-10-07

Official Source

View FDA Recall →

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

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