Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2015 - (Recall #: Z-2491-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 23, 2015

Date Posted: September 9, 2015

Recall Number: Z-2491-2015

Event ID: 71882

Reason for Recall:

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.

Status: Terminated

Product Quantity: 11

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.

Voluntary or Mandated:

Voluntary: Firm initiated