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Terminated

U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals.

FDA Recall Z-1335-2012 · Posted 2012-04-05

Recalling FirmMilabs Bv
Recall StatusTerminated
Product CodeRFK
Date Initiated2012-04-15
Date Terminated2012-08-29
Product Quantity2

Reason for Recall

These products have doors which are not equipped with at least one safety interlock which physically disconnects power to the high voltage power supply for the x-ray source. Additionally, these products do not have a certification label and the identification labels do not include the month and year of manufacture.

Firm Action

A notification will be sent to all affected purchasers by April 15, 2012. The manufacturer will bring the products into compliance with the applicable performance standards within 60 days. Specifically at least one door safety interlock will be replaced per door and revised labels will be produced and applied to the system. These corrections will be made in accordance with MILabs instructions by a MILabs installation and service engineer.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution -- Indiana and North Carolina.

Official Source

View FDA Recall →

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

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