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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69870

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

Open FDA event record

Event summary

Timeline bucket
October 14, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips 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

Philips Multi Diagnost Eleva II

Z-1044-2015
Recall number
Z-1044-2015
Initiated
October 14, 2013
Classification
Class II
Status
Terminated
Quantity
238

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

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

The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Code information

Product Code: 708036

Distribution pattern

Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.

device · product 2 of 2

Philips Multi Diagnost Eleva with FlatDetector

Z-1045-2015
Recall number
Z-1045-2015
Initiated
October 14, 2013
Classification
Class II
Status
Terminated
Quantity
238

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

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

The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Code information

Product Code: 708037

Distribution pattern

Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.

Field note

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