Facility

MICRO-X LTD

8 recall(s) on record — most severe on record: Class II.

Key facts

8recalls · worst Class II

1inspections · worst OAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012855798
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	A14 6 MAB Eastern Promenade Tonsley South Australia, AU 5042
Registration status	Active · expires 2026
Parent company	MICRO-X LTD (owner-operator 10057299)

Activity by year

Recalls (8)
Inspections (1)

Devices registered here (1)

System, X-Ray, Mobile
Product code IZL (opens in a new tab) · Class II · Radiology · 21 CFR 892.1720

Recalls & enforcement

Class IIOngoing2026-03-27
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Class IIOngoing2025-04-04
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Class IIOngoing2025-03-28
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Class IIOngoing2024-10-23
During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displaye…
Class IIOngoing2024-10-22
Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degre…
Class IIOngoing2023-11-28
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Class IIOngoing2023-05-31
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
Class IIOngoing2022-08-31
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

FDA inspections (1)

OAI2024-05-23
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by MICRO-X LTD

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MICRO-X LTD (FEI 3012855798) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012855798-micro-x-ltd/

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