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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88336

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

Open FDA event record

Event summary

Timeline bucket
June 08, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips North America Llc

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

5 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 5

728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

Z-2314-2021
Recall number
Z-2314-2021
Initiated
June 08, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
3 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software will result in

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 setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Code information

S/N UDI: 87013 (01)00884838059474(21)87013 87008 (01)00884838059474(21)87008 87011 (01)00884838059474(21)87011 Software Version 4.1.10 SynchRight Option

Distribution pattern

US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

device · product 2 of 5

Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

Z-2315-2021
Recall number
Z-2315-2021
Initiated
June 08, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
2 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software will result in

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 setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Code information

Model: 728321 S/N UDI: 40012 (01)00884838059498(21)40012 Model: 728332 40004 (01)00884838059504(21)40004 Software Version: 4.1.10 SynchRight Option

Distribution pattern

US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

device · product 3 of 5

728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

Z-2316-2021
Recall number
Z-2316-2021
Initiated
June 08, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
3 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software will result in

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 setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Code information

Serial Number: 300099 300106 300143 Software Version 4.1.10 SynchRight Option

Distribution pattern

US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

device · product 4 of 5

728332 IQon Spectral CT-Computed Tomography X-ray system

Z-2317-2021
Recall number
Z-2317-2021
Initiated
June 08, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software will result in

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 setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Code information

Serial Number/UDI: 60001 (01)00884838059542(21)60001, 60005 (01)00884838059542(21)60005, 60015 (01)00884838059542(21)60015, 60017 (01)00884838059542(21)60017, 860026 (01)00884838059542(21)860026, 860035 (01)00884838059542(21)860035, 860053 (01)00884838059542(21)860053 860074 (01)00884838059542(21)860074, 860108 (01)00884838059542(21)860108, 860109 (01)00884838059542(21)860109. Software Version 4.7.7 SynchRight Option

Distribution pattern

US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

device · product 5 of 5

728333 Spectral CT 7500 -Computed Tomography X-ray system

Z-2318-2021
Recall number
Z-2318-2021
Initiated
June 08, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
1 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software will result in

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 setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Code information

Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option

Distribution pattern

US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.