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

Trolley for Intera/NT MRI System

FDA Recall Z-1028-04 · Posted 2004-07-20

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-05-13
Date Terminated2005-04-08
Product Quantity57 devices

Reason for Recall

Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley.

Firm Action

The firm sent a letter via certified mail to all customers on May 13, 2004 instructing their customers to check the position of the tabletop to ensure it is correctly aligned on the trolley. The firm is implementing a design modification beginning May 13, 2004. A field service engineer will contact the customers to arrange for installation of the retrofit for the trolley.

Root Cause

Other

Distribution Pattern

Product was distributed to hospitals and medical centers nationwide.

Official Source

View FDA Recall →

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

↑