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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92238

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

Open FDA event record

Event summary

Timeline bucket
April 12, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS HEADQUARTERS CAMBRIDGE

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

4 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 4

Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

Z-1622-2023
Recall number
Z-1622-2023
Initiated
April 12, 2023
Classification
Class II
Status
Ongoing
Quantity
7 units US and 76 unit OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

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

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Code information

UDI-Di: (01)00884838105508(21) Serial Numbers: 34053, 34092, 34164, 34168, 34179, 34195, 34200 (US) OUS: System Serial Number 34010 34020 34061 34070 34107 34108 34127 34142 34147 34157 34158 34161 34166 34176 34177 34178 34180 34194 34202 500453 500499 500501 500504 500506 500508 500511 500518 500529 550004 550023 550025 550034 550041 550052 550065 550069 550077 550079 550084 550086 550093 550103 550107 550114 550115 550119 550121 550128 550130 550140 550141 550150 550162 550164 550169 550174 550176 550181 550187 550188 550191 550194 550195 550203 550212 550234 550241 550248 550249 550251 550256 550266 550270 552038 552040 554023

Distribution pattern

AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam

device · product 2 of 4

Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)

Z-1623-2023
Recall number
Z-1623-2023
Initiated
April 12, 2023
Classification
Class II
Status
Ongoing
Quantity
22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

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

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Code information

UDI-DI: (01)00884838085015(21) Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378 Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378

Distribution pattern

AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam

device · product 3 of 4

Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)

Z-1624-2023
Recall number
Z-1624-2023
Initiated
April 12, 2023
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

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

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Code information

UDI-DI: (01)00884838103467 (21) Serial Number: 102342065

Distribution pattern

AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam

device · product 4 of 4

Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)

Z-1625-2023
Recall number
Z-1625-2023
Initiated
April 12, 2023
Classification
Class II
Status
Ongoing
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

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

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Code information

UDI-DI: (01)00884838103474(21) Serial Number: 530537 554032 554060 554065 554078

Distribution pattern

AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam