The Recall Desk
HighFDA (Devices)·Z-0442-2021·Announced 2020-11-25

GE v|tome|x L Series X-ray Systems Recalled for Warning Signal Defect

GE Inspection Technologies is recalling v|tome|x L Series X-ray systems because pre-warning signals may fail to activate if the warm-up mode is not completed.

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 safety-critical warning signal failure in an X-ray system, which poses a risk of harm (radiation exposure) even though no specific injuries have been reported in the source text.

Plain-English summary

GE Inspection Technologies LLC is recalling v|tome|x L Series non-destructive testing cabinet X-ray systems. The affected models include the L240, L300, and L450. These systems were distributed in the USA and Canada.

The recall was initiated after testing of a v/tome/x L450 system revealed that the pre-warning signals do not provide audible and visible warnings within the cabinet if the "warm up" mode was not completed after initializing the system when first turned on. This defect could potentially allow the system to operate without the required safety warnings being displayed or heard.

Users of these systems should stop using them and contact GE Inspection Technologies for further instructions on how to resolve the issue. The recall is classified as Class II by the FDA.

The recalled product

Product
v|tome|x L Series non-destructive testing cabinet x-ray systems
Manufacturer
Ge Inspection Technologies Llc
Category
Medical Device — Imaging Equipment
Hazard

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 (2)

  • v/tome/x L Series (L240
  • L300 or L450)

Distribution

Distribution scope not specified by the agency.

Related recalls

Same hazard · radiation exposure

See all →