—#116015

Product

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

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052640
Affected lot / code info: Model #: 882456; Serial #: 2004

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Distributed to one customer in Ohio.

Timeline

Recall initiated: 2012-12-20
Posted by FDA: 2013-04-01
Terminated: 2013-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.