The Recall Desk
HighFDA (Devices)·Z-0526-2015·Announced 2014-12-24

Varian On-Board Imager X-ray Generators Recalled for Missing Ground Wire

Varian Medical Systems is recalling 32 On-Board Imager systems because the X-ray generators are missing a required ground wire.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a missing safety ground wire on a medical device, which poses a risk of electrical shock or equipment malfunction, but the source text does not report any injuries or illnesses.

Plain-English summary

Varian Medical Systems, Inc. is recalling 32 units of the Varian On-Board Imager Advanced Imaging System. The recall is due to a defect identified by the X-ray generator supplier, CPI, where the VMS150 X-ray Generators were shipped without a ground wire connecting the EMI braid on the induction assembly cable to the ground stud on the lid of the High Voltage Module.

The affected devices are used to verify correct patient position in relation to the isocenter and to verify treatment fields in relation to anatomical and/or fiducial landmarks. The recall covers units distributed worldwide.

Healthcare facilities should contact Varian Medical Systems for instructions on how to resolve the missing ground wire issue.

The recalled product

Product
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
Affected units
32

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part Number P1003290001

Distribution

Distribution scope not specified by the agency.