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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77559

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

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Event summary

Timeline bucket
June 21, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Elekta, 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

MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ¿ for Medical Oncology use, Radiation Oncology use, or the two together. It lets users:  Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.  Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology.  Import, view, annotate, adjust, enhance, manage and archive images.  Compare radiation treatment plans and evaluate dose coverage.  Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators.  Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ¿ reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user.  View reference images to setup treatment. MOSAIQ¿ refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions.  Record actual delivered radiation values in an electronic chart to track treatment. MOSAIQ¿ is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.

Z-2633-2017
Recall number
Z-2633-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Elekta, Inc.
Quantity
355 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.

Code information

None

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of ANTIGUA AND BARBUDA, AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, CHEZ REPUBLIC, GERMANY, HUNGARY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, AND UK

Field note

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