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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98644

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 27, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Micro-X Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Z-1918-2026
Recall number
Z-1918-2026
Initiated
March 27, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Micro-X Ltd.
Quantity
32 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
X-Ray generator may malfunction resulting in the X-Ray being inoperable.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

X-Ray generator may malfunction resulting in the X-Ray being inoperable.

Code information

Lot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462

Distribution pattern

US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.