Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2491-2015 · Posted 2015-08-31

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeOUO
Date Initiated2015-07-23
Date Terminated2018-06-26
Product Quantity11

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.

Firm Action

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

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103483INGENUITY TF PET/MRPhilips Healthcare (Cleveland) · 2011-11-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑