—#116049

Product

Ingenuity TF PET/CT. Diagnostic imaging system

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. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.

Why it was recalled

The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical Systems (Cleveland), Inc. sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated January 21, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact your local Philips representative or Philips Healthcare office for further information concerning this issue.

Recalling firm

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

Distribution

Distribution pattern: Distributed only in Ohio.

Timeline

Recall initiated: 2013-01-21
Posted by FDA: 2013-02-28
Terminated: 2013-07-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116049. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.