Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95450

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

Open FDA event record

Event summary

Timeline bucket
September 06, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

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

SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.

Z-0316-2025
Recall number
Z-0316-2025
Initiated
September 06, 2024
Classification
Class II
Status
Ongoing
Quantity
3

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software with certain versions of the control board may occasionally fail to

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

Code information

UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001

Distribution pattern

US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.

device · product 2 of 2

The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.

Z-0317-2025
Recall number
Z-0317-2025
Initiated
September 06, 2024
Classification
Class II
Status
Ongoing
Quantity
30

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software with certain versions of the control board may occasionally fail to

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

Code information

UDI-DI: 04540217065271. Serial Numbers: MQ493E3E3001, MQ493E3E3002, MQ493E3D6002, MQ493E3D5001, MQ493E3D8002, MQ493E3E1002, MQ493E3D4002, MQ493E3D6003, MQ493E3DA002, MQ493E3E2001, MQ493E3E2002, MQ493E3E1001, MQ493E3DC001, MQ493E3D9001, MQ493E3D4005, MQ493E3D7001, MQ493E3DB002, MQ493E3D2002, MQ493E3D4001, MQ493E3D7002, MQ493E3D4003, MQ493E3D4004, MQ493E3D2001, MQ493E3D8001, MQ493E3D5002, MQ493E3DB001, MQ493E3D2003, MQ493E3DA001, MQ493E3D6001, MQ493E3E1003

Distribution pattern

US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.