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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88393

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

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Event summary

Timeline bucket
July 22, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips Medical Systems Gmbh, DMC

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

CombiDiagnost R90 Software Version R1.0 and R1.1

Z-2357-2021
Recall number
Z-2357-2021
Initiated
July 22, 2020
Classification
Class II
Status
Ongoing
Quantity
322 systems; 66 in US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

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

Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.

Code information

Model 706100

Distribution pattern

US Nationwide Distribution

Field note

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