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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97699

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

Open FDA event record

Event summary

Timeline bucket
September 25, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS

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

3 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 3

Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;

Z-0375-2026
Recall number
Z-0375-2026
Initiated
September 25, 2025
Classification
Class II
Status
Ongoing
Recalling firm
PHILIPS MEDICAL SYSTEMS
Quantity
105 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.

Code information

1. Product Code (REF): 728143; UDI-DI: 00884838085015; Serial Numbers: 500417, 500404, 500408, 500277, 500037, 500475, 500243, 500028, 500024, 510003, 33022, 500521, 500444, 500305, 500174, 500150, 500029, 500018, 500546, 500472, 510023, 510008, 500532, 500483, 500471, 500446, 500258, 500195, 500568, 33005, 2. Product Code (REF): 728144; UDI-DI: 00884838105508; Serial Numbers: 550375, 550259, 550241, 550195, 550187, 550159, 550116, 550063, 550052, 55400406111940, 550298, 550092, 550188, 5400406113211, 550467, 550328, 550177, 550136, 34318, 550300, 550296, 550248, 550234, 34252, 34224, 34217, 34176, 34157, 34147, 34142, 34108, 550605, 550580, 550129, 550103, 550056, 500509, 34499, 34458, 34405, 34136, 550040, 550447, 550041, 550359, 550350, 34546, 34188, 550686, 550065, 550059, 550025, 500506, 34237, 550474, 550141, 550115, 34401, 552001, 34529, 34408, 34532, 34516, 34280, 34259, 34251, 34223, 34208, 34179, 34174, 34159, 34137, 34082, 34080, 34003;

Distribution pattern

Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen;

device · product 2 of 3

Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

Z-0376-2026
Recall number
Z-0376-2026
Initiated
September 25, 2025
Classification
Class II
Status
Ongoing
Recalling firm
PHILIPS MEDICAL SYSTEMS
Quantity
165 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.

Code information

Product Code (REF): 728285; UDI-DI: 00884838113237; Serial Numbers: 800031, 800073, 800070, 35064, 35056, 35043, 35029, 800084, 800083, 800076, 800063, 800058, 800048, 800040, 800039, 800038, 800034, 800033, 800028, 800026, 800021, 800018, 800015, 800011, 800010, 800078, 800071, 35078, 35068, 35048, 35036, 800023, 800008, 800004, 800001, 35073, 35069, 35067, 35058, 35051, 35044, 35034, 35031, 35027, 35019, 35015, 35009, 35001, 800065, 35062, 35042, 35040, 35022, 35016, 35059, 800081, 800062, 800003, 35081, 35065, 35061, 35057, 35053, 35052, 35045, 35041, 35035, 35008, 800005, 35006, 800041, 35080, 800056, 35070, 35033, 35021, 800079, 800077, 800069, 800055, 800054, 800053, 800052, 800007, 800002, 35079, 35071, 35063, 35055, 35046, 35017, 35011, 35007, 35002, 800075, 800045, 800044, 800043, 800029, 800027, 800025, 800024, 800016, 800013, 800009, 800051, 800042, 800061, 800046, 800030, 800019, 800014, 800006, 800074, 800066, 35054, 35018, 800060, 800059, 800072, 35032, 35023, 35003, 800080, 800047, 35039, 35038, 35004, 76001, 35077, 35066, 35060, 35030, 35025, 35013, 35012, 35010, 35037, 35082, 35072, 35005, 35026, 800057, 800067, 800037, 800036, 800032, 800020, 35076, 35075, 35074, 35050, 35049, 35047, 35028, 35024, 35020, 35014, 800050, 800049, 800082, 800064, 800022, 800017, 800012;

Distribution pattern

Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen;

device · product 3 of 3

Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

Z-0377-2026
Recall number
Z-0377-2026
Initiated
September 25, 2025
Classification
Class II
Status
Ongoing
Recalling firm
PHILIPS MEDICAL SYSTEMS
Quantity
1 unit (OUS only)

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.

Code information

Product Code (REF): 728146; UDI-DI: None; Serial Number: 540000

Distribution pattern

Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen;