FDA Medical Device Recalls (openFDA)
Milabs Bv: U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals.
- Recall number
- Z-1335-2012
- Recalling firm
- Milabs Bv
- Product
- U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals.
- Status
- Terminated
- Initiated
- 2012-04-15
- Posted
- 2012-04-05
- Terminated
- 2012-08-29
- Reason
- 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
- 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
- 2
- Distribution
- Nationwide Distribution -- Indiana and North Carolina.
- Lot, serial or model codes
- 2 systems
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RFK
- Firm FEI
- 3008406612
- Firm city
- Utrecht
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28