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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76175

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

Open FDA event record

Event summary

Timeline bucket
May 19, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Toshiba American Medical Systems Inc

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

Toshiba Kalare DREX-KL80 X-ray generator

Z-1397-2017
Recall number
Z-1397-2017
Initiated
May 19, 2016
Classification
Class II
Status
Terminated
Quantity
254

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination

Code information

Model : KXO-80XD

Distribution pattern

USA ( nationwide ) Distribution to the states of : WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.

device · product 2 of 2

Toshiba Ultimax DREX-ULT80 X-ray generator

Z-1398-2017
Recall number
Z-1398-2017
Initiated
May 19, 2016
Classification
Class II
Status
Terminated
Quantity
254

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination

Code information

Model : KXO-80XM

Distribution pattern

USA ( nationwide ) Distribution to the states of : WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.