—#139267

Product

Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems

FDA product code: OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K103483
Affected lot / code info: M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.

Why it was recalled

Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.

Root cause (FDA determination)

Software design

Action the firm took

On July 23, 2015 the firm sent Field Safety Notices to their customers.

Recalling firm

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

Distribution

Distribution pattern: Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.

Timeline

Recall initiated: 2015-07-23
Posted by FDA: 2015-08-31
Terminated: 2018-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139267. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.