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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 Spectral CT Systems Recalled for Unintended Gantry and Table Motion

Agency Publication Date: June 26, 2025
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Summary

Philips North America Llc has recalled 370 Spectral CT Computed Tomography X-ray systems (Part No. 728333) due to software defects. These issues can cause the gantry or the patient table to move unexpectedly and without command, which may lead to the equipment making physical contact with patients or medical staff. Additionally, these software issues can negatively affect the overall scanning and diagnostic performance of the CT system. The affected units were distributed in 19 US states and multiple foreign countries between May and June 2025.

Risk

The unintended movement of heavy medical equipment like a CT gantry or table poses a risk of impact or crushing injuries to both operators and patients. Furthermore, software-related performance issues could lead to suboptimal imaging, potentially affecting diagnosis or necessitating repeat radiation exposure.

What You Should Do

  1. This recall involves Philips Spectral CT Computed Tomography X-ray systems (Part No. 728333) which may experience unintended mechanical motion due to software issues.
  2. Identify if your equipment is affected by checking the serial numbers or Unique Device Identifier (UDI) codes on the machine's label or within the system software. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to prevent unintended motion incidents.
  4. Contact Philips North America Llc or your authorized distributor to coordinate a software update or correction to address the gantry motion and CT performance issues.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional safety information or to report any incidents involving this equipment.

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: Spectral CT. Computed tomography X-ray system.by Philips
Model / REF:
728333
Serial Numbers (293):
10013
10014
10015
10016
10017
10018
10019
10020
10021
10022
10023
10024
10025
10027
10031
10032
10033
10034
10035
10036
10038
10039
10040
10041
10042
10043
10044
10045
10046
10047
10048
10049
10050
10052
10053
10055
10056
10057
10058
10059
10060
10061
10062
10063
10065
10066
10067
10068
10069
10070
UDI (292):
(01)00884838101111(21)10014
(01)00884838101111(21)10015
(01)00884838101111(21)10016
(01)00884838101111(21)10017
(01)00884838101111(21)10018
(01)00884838101111(21)10019
(01)00884838101111(21)10020
(01)00884838101111(21)10021
(01)00884838101111(21)10022
(01)00884838101111(21)10023
(01)00884838101111(21)10024
(01)00884838101111(21)10025
(01)00884838101111(21)10027
(01)00884838101111(21)10031
(01)00884838101111(21)10032
(01)00884838101111(21)10033
(01)00884838101111(21)10034
(01)00884838101111(21)10035
(01)00884838101111(21)10036
(01)00884838101111(21)10038
(01)00884838101111(21)10039
(01)00884838101111(21)10040
(01)00884838101111(21)10041
(01)00884838101111(21)10042
(01)00884838101111(21)10043
(01)00884838101111(21)10044
(01)00884838101111(21)10045
(01)00884838101111(21)10046
(01)00884838101111(21)10047
(01)00884838101111(21)10048
(01)00884838101111(21)10049
(01)00884838101111(21)10050
(01)00884838101111(21)10052
(01)00884838101111(21)10053
(01)00884838101111(21)10055
(01)00884838101111(21)10056
(01)00884838101111(21)10057
(01)00884838101111(21)10058
(01)00884838101111(21)10059
(01)00884838101111(21)10060
(01)00884838101111(21)10061
(01)00884838101111(21)10062
(01)00884838101111(21)10063
(01)00884838101111(21)10065
(01)00884838101111(21)10066
(01)00884838101111(21)10067
(01)00884838101111(21)10068
(01)00884838101111(21)10069
(01)00884838101111(21)10070
(01)00884838101111(21)10071
Date Ranges: Manufactured between May 2025 and June 2025

Quantity affected: 370 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97010
Status: Active
Manufacturer: Philips North America Llc
Sold By: Authorized medical device distributors; Direct sales from Philips North America Llc
Manufactured In: United States
Units Affected: 370 units
Distributed To: Arizona, California, Colorado, Florida, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, West 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.

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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.