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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84616

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

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Event summary

Timeline bucket
January 06, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Carestream Health, 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

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

Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator shutter are accomplished at the operator console.

Z-0806-2020
Recall number
Z-0806-2020
Initiated
January 06, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carestream Health, Inc.
Quantity
79

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

Code information

DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093

Distribution pattern

Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.