Z-1335-2012

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

Name: Z-1335-2012 U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals
Creator: Milabs Bv
Published: 2012-04-15
License: https://open.fda.gov/license/

Milabs BV / initiated 2012-04-15 / Terminated / root cause: labeling and UDI

FDA source

Milabs Bv began a recall of U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals on 2012-04-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1335-2012
Status: Terminated
Initiated: 2012-04-15
Posted: 2012-04-05
Terminated: 2012-08-29
Recalling firm: Milabs BV
Product: U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals.
Product code: RFK Laser Vision
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.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
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.
Quantity in commerce: 2
Distribution: Nationwide Distribution -- Indiana and North Carolina.
Product codes and lots: 2 systems

Product code RFK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)