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Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Recalled September 9, 2015 · FDA recall Z-2491-2015 · Philips Medical Systems (Cleveland)
Hazard
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. · FDA Class II
Units
11
Sold at
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.
Description
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.
Product
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →