Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96638

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 04, 2025
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

2 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 2

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

Z-1669-2025
Recall number
Z-1669-2025
Initiated
April 04, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Micro-X Ltd.
Quantity
13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Code information

(Serial Number UDI-DI) 352 (01)09357123000051(11)230823(21)00352 334 (01)09357123000051(11)220921(21)00334 389 (01)09357123000051(11)230814(21)00383 383 (01)09357123000051(11)230814(21)00383 384 (01)09357123000051(11)230816(21)00384 382 (01)09357123000051(11)230809(21)00382 386 (01)09357123000051(11)230908(21)00386 385 (01)09357123000051(11)230906(21)00385 387 (01)09357123000051(11)230914(21)00387 388 (01)09357123000051(11)230916(21)00388 364 01)09357123000051(11)230705(21)00364 390 (01)09357123000051(11)231013(21)00390 395 (01)09357123000051(11)231106(21)00395

Distribution pattern

US: NJ, WA, Puerto Rico OUS: None

device · product 2 of 2

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

Z-1670-2025
Recall number
Z-1670-2025
Initiated
April 04, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Micro-X Ltd.
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Code information

Serial Number/UDI-DI - 349 (01)09357123000037(11)230209(21)00349 348 (01)09357123000037(11)230123(21)00348 350 (01)09357123000037(11)230328(21)00350. 351 (01)09357123000037(11)230413(21)00351 361 (01)09357123000037(11)230503(21)00361

Distribution pattern

US: NJ, WA, Puerto Rico OUS: None