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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85810

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

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Event summary

Timeline bucket
June 02, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips North America, LLC

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

EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

Z-2523-2020
Recall number
Z-2523-2020
Initiated
June 02, 2020
Classification
Class II
Status
Terminated
Quantity
52

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

Code information

Serial Numbers SN16000004 SN17000018 SN17000020 SN17000025 SN17000026 SN18000002 SN18000004 SN18000005 SN16000002 SN16000006 SN16000011 SN16000013 SN16000017 SN16000022 SN16000025 SN16000028 SN16000029 SN16000030 SN16000031 SN16000036 SN16000037 SN16000039 SN16000041 SN16000042 SN16000043 SN16000044 SN16000045 SN16000048 SN16000054 SN16000056 SN17000001 SN17000006 SN17000008 SN17000015 SN17000017 SN17000019 SN17000021 SN17000023 SN17000027 SN17000028 SN17000029 SN17000031 SN17000032 SN17000033 SN17000034 SN17000035 SN17000036 SN17000037 SN17000038 SN18000001 SN18000003 SN18000009

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CT, FL, GA, HI, IL, LA, MA, MD, MI, MS, MT, NC, NY, TN, TX and the country of Panama.