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

SMV FX-40 Nuclear Camera

FDA Recall Z-1393-04 · Posted 2004-08-24

Recalling FirmGeneral Electric Med Systems
Recall StatusTerminated
Product CodeIYX
Date Initiated2004-07-30
Date Terminated2006-07-24
Product Quantity65

Reason for Recall

The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become loose, fail, or back out.

Firm Action

The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector''s radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become lose, fail, or back out.

Root Cause

Other

Distribution Pattern

Inside the US. Manufactured and distributed from 1993 - 2000.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935273VISION FX 40 & 80 SERIES GAMMA CAMERASummit Nuclear · 1994-04-18

Official Source

View FDA Recall →

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

↑