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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88604

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

Open FDA event record

Event summary

Timeline bucket
August 16, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biodex 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

Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

Z-2580-2021
Recall number
Z-2580-2021
Initiated
August 16, 2021
Classification
Class II
Status
Terminated
Quantity
829 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration

Code information

Serial Number range:17081557-21062362 UDI: 00718175003305

Distribution pattern

Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt France Hong Kong HUNGARY Iceland India Iraq Ireland ISRAEL Isreal Italy Japan JORDAN Kuwait Lebanon Libya Malaysia MALTA Mexico Morocco Netherlands New Zealand Oman Pakistan Palestine Panama Peru Philippines Poland Portugal PR Puerto Rico Qatar Romania Russia Saudi Arabia Singapore South Africa South Korea Spain Sweden Taiwan UAE United Arab Emirates United Kingdom Venezuela

device · product 2 of 2

AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332

Z-2581-2021
Recall number
Z-2581-2021
Initiated
August 16, 2021
Classification
Class II
Status
Terminated
Quantity
429 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration

Code information

Serial Number Range:17080651-21061047 UDI: 00718175003329

Distribution pattern

Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt France Hong Kong HUNGARY Iceland India Iraq Ireland ISRAEL Isreal Italy Japan JORDAN Kuwait Lebanon Libya Malaysia MALTA Mexico Morocco Netherlands New Zealand Oman Pakistan Palestine Panama Peru Philippines Poland Portugal PR Puerto Rico Qatar Romania Russia Saudi Arabia Singapore South Africa South Korea Spain Sweden Taiwan UAE United Arab Emirates United Kingdom Venezuela