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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips Incisive CT and CT 5300 Systems Recalled for Multiple Software Issues

Agency Publication Date: October 27, 2025
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Summary

Philips Medical Systems is recalling approximately 271 units of its Incisive CT and CT 5300 medical imaging systems due to several software failures. These issues range from unintended movement of the scanner couch to incorrect radiation dose settings and missing cardiac data files. The software versions affected are 5.1.0.X and 5.1.1.X.

Risk

These defects can lead to serious risks including physical injury from unexpected equipment movement, insufficient radiation doses resulting in noisy images, or the need for patients to undergo repeat radiation exposure (rescans) due to missing or incorrect data.

What You Should Do

  1. This recall affects Philips Incisive CT and CT 5300 systems running software versions 5.1.0.X and 5.1.1.X. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately to avoid potential safety risks associated with unintended movement or incorrect radiation dosing.
  3. Contact Philips Medical Systems or your distributor to arrange for a software correction, repair, or further instructions based on the specific software fault found in your unit.
  4. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) for additional information or questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Incisive CT
Variants: Software Versions: 5.1.0.X & 5.1.1.X
Model / REF:
728143
728144
Serial Numbers (105):
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
550375
550259
550241
550195
550187
550159
550116
550063
550052
55400406111940
550298
550092
550188
5400406113211
550467
550328
550177
550136
34318
550300
UDI:
00884838085015
00884838105508

Software versions 5.1.0.X & 5.1.1.X affected.

Product: CT 5300
Variants: Software Versions: 5.1.0.X & 5.1.1.X
Model / REF:
728285
Serial Numbers (165):
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
UDI:
00884838113237

Software versions 5.1.0.X & 5.1.1.X affected.

Product: Incisive CT for Brazil SKD
Variants: Software Versions: 5.1.0.X & 5.1.1.X
Model / REF:
728146
Serial Numbers:
540000

Recall #: Z-0377-2026; Software versions 5.1.0.X & 5.1.1.X affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97699
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS
Sold By: hospitals; medical clinics; imaging centers
Manufactured In: United States
Units Affected: 3 products (105 units; 165 units; 1 unit (OUS only))
Distributed To: Alabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.