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Terminated

Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

FDA Recall Z-1029-2013 · Posted 2013-04-01

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2012-12-20
Date Terminated2013-06-18
Product Quantity1

Reason for Recall

Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.

Firm Action

Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated December 19, 2012 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. A Philips Service Engineer will contact the customer for implementation of the software update on the affected system.

Root Cause

Software design

Distribution Pattern

Distributed to one customer in Ohio.

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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