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

GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.

FDA Recall Z-1709-2008 · Posted 2008-09-20

Recalling FirmOEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2008-07-02
Date Terminated2009-01-20
Product Quantity660 units

Reason for Recall

Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EE

Firm Action

Domestic customer notification letters were sent via certified mail on 07/02/2008. They were advised to have the Maximum EER assessed and to discontinue use if the maximum limits were exceeded.

Root Cause

Equipment maintenance

Distribution Pattern

Nationwide Distribution including states of CA, FL, MS, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963952SERIES 9600 MOBILE DIGITAL IMAGING SYSTEMGe Dec Medical Systems · 1996-12-23

Official Source

View FDA Recall →

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

↑