GE x|tome|x L240 X-ray System Recalled for Lead Shield Defect
GE Inspection Technologies is recalling two x|tome|x L240 X-ray systems because a lead shield fell out of position, creating potential radiation exposure gaps.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II and involves a risk-of-harm product (radiation shielding failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Inspection Technologies, LP is recalling two units of the x|tome|x L240 an Cabinet X-ray system. The recall was initiated after it was discovered that the upper left corner-shaped lead shield in the window of one of the doors had lost adhesion and fallen out of position. This defect could lead to gaps in the shielding.
The affected units were distributed in the United States to the states of Ohio and Pennsylvania. The specific serial number for the affected unit is PA1260.
Consumers and facilities with this equipment should contact GE Inspection Technologies for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
- Manufacturer
- GE Inspection Technologies, LP
- Affected units
- 2
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)
- SN - PA1260
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Inspection Technologies, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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