RegWardenFDA facility compliance records
Recall

Class II — Micro-X Ltd.

Recalling firmMICRO-X LTD
Registered facilityMICRO-X LTD (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonMobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
ProductMICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Quantity18
DistributionUS Nationwide Distribution: NJ, CA, PR
Initiated2023-11-28
Classified2024-12-12
Recall numberZ-0665-2025
InitiationVoluntary: Firm initiated

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

Cite this record

RegWarden. “Class II recall — Micro-X Ltd. (Z-0665-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95617/

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