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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 Brilliance CT Big Bore Systems Recalled for Unintended Motion Risk

Agency Publication Date: April 23, 2025
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Summary

Philips North America Llc is recalling 630 units of the Brilliance CT Big Bore Computed Tomography X-Ray System (Software Version 4.8.0.10430) because of a defect in the interventional control software. This defect can cause the machine's gantry or table to move unexpectedly without operator input. No injuries or incidents have been reported, but the equipment is being corrected to prevent potential accidents.

Risk

The software issue causes unintended motion which can result in the heavy gantry or table colliding with a healthcare worker or a patient during an imaging procedure.

What You Should Do

  1. This recall affects Philips Brilliance CT Big Bore systems (Software Version 4.8.0.10430) and includes Models 728242, 728243, and 728244.
  2. Identify your equipment by checking the model number and serial number printed on the device label, or the Unique Device Identifier (UDI) barcode on the packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled medical device immediately and quarantine it if possible.
  4. Contact Philips North America Llc or your local medical equipment distributor to arrange for a system correction, replacement, or hardware/software modification.
  5. Call the FDA at 1-888-463-6332 if you have additional questions or need further assistance regarding this safety alert.

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: Philips Brilliance CT Big Bore Computed Tomography X-Ray System
Variants: Software Version 4.8.0.10430
Model / REF:
728242
728243
728244
Serial Numbers (644):
7013
7014
7032
7034
7038
7056
7058
7060
7062
7064
7068
7072
7076
7081
7087
7096
7097
7099
7104
7123
7124
7128
7135
7137
7138
7148
7152
7154
7157
7162
7163
7173
7177
7179
7191
7196
7203
7212
7220
7221
7229
7231
7240
7243
7245
7246
7247
7254
7256
7258
UDI (551):
00884838098725(21)7014
00884838098725(21)7032
00884838059450(21)7056
00884838098725(21)7060
00884838098725(21)7062
00884838098725(21)7064
00884838098725(21)7072
00884838098725(21)7087
00884838059450(21)7096
00884838059450(21)7123
00884838059450(21)7124
00884838098725(21)7128
00884838098725(21)7135
00884838098725(21)7154
00884838098725(21)7163
00884838098725(21)7179
00884838098725(21)7191
00884838098725(21)7220
00884838098725(21)7221
00884838098725(21)7229
00884838059450(21)7240
00884838098725(21)7245
00884838098725(21)7246
00884838098725(21)7247
00884838098725(21)7254
00884838098725(21)7256
00884838098725(21)7282
00884838098725(21)7283
00884838098725(21)7292
00884838098725(21)7297
00884838098725(21)7304
00884838098725(21)7306
00884838098725(21)7309
00884838098725(21)7311
00884838098725(21)7331
00884838098725(21)7332
00884838059450(21)7333
00845225003036(10)0302624730(21)7336
00845225003036(10)0302624730(21)7341
00845225003036(10)0302624730(21)7345
00845225003036(10)0302624730(21)7348
00845225003036(10)0302624730(21)7353
00884838059450(21)7355
00884838059450(21)7362
00845225003036(10)0302624730(21)7364
00845225003036(10)0302624730(21)7367
00845225003036(10)0302624730(21)7373
00884838098725(21)7396
00845225003036(10)0302624730(21)7401
00845225003036(10)0302624730(21)7406

Software Version 4.8.0.10430 affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96667
Status: Active
Manufacturer: Philips North America Llc
Sold By: Hospitals; Diagnostic Imaging Centers; Medical Equipment Distributors
Manufactured In: United States
Units Affected: 630 units
Distributed To: Nationwide

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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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.