Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2491-2015

July 23, 2015

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 71882
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-2491-2015

Official wording

Reason: 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.

Code information: M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.