Brilliance iCT; Product Code (REF): 728306;
Brilliance iCT; Product Code (REF): 728306; was recalled because as part of the ct systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. one or more of these fasteners may not be torqued to specification. if multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. while there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.. If you have this product, stop using it until you verify your lot or model details.
By RecallRadar Editorial Team
Sourced from FDA. Last verified March 15, 2026.
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- Date announced
- February 18, 2026
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
Brilliance iCT; Product Code (REF): 728306; was recalled because as part of the ct systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. one or more of these fasteners may not be torqued to specification. if multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. while there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.. If you have this product, stop using it until you verify your lot or model details.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Philips north america llc
- Category
- medical
- Source agency
- FDA
- Announced
- February 18, 2026
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
Product Code (REF): 728306; UDI-DI: 00884838059474; Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126, 87127, 87128, 87129, 87130, 87135, 87143, 87148, 87152, 87153, 87157, 87160, 87162, 87167, 87173, 87174, 87176, 87181, 87197, 87198, 87199, 87200 , 87202, 87203, 87204, 87205, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213 , 87214, 87215, 87216, 87217, 87218, 87219, 87220, 87221;
| # | Model |
|---|---|
| 1 | Product Code (REF): 728306; UDI-DI: 00884838059474; Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126, 87127, 87128, 87129, 87130, 87135, 87143, 87148, 87152, 87153, 87157, 87160, 87162, 87167, 87173, 87174, 87176, 87181, 87197, 87198, 87199, 87200 , 87202, 87203, 87204, 87205, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213 , 87214, 87215, 87216, 87217, 87218, 87219, 87220, 87221; |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1Stop using the affected product until you verify whether your item is impacted.
- 2Check the official recall notice and match your model, lot, or serial details.
- 3Follow the official instructions for repair, replacement, refund, or disposal.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- February 18, 2026
- Last reviewed by RecallRadar
- March 15, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists Product Code (REF): 728306; UDI-DI: 00884838059474; Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126, 87127, 87128, 87129, 87130, 87135, 87143, 87148, 87152, 87153, 87157, 87160, 87162, 87167, 87173, 87174, 87176, 87181, 87197, 87198, 87199, 87200 , 87202, 87203, 87204, 87205, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213 , 87214, 87215, 87216, 87217, 87218, 87219, 87220, 87221;.
What is the remedy for this recall?
Follow the official instructions for repair, replacement, refund, or disposal on the philips north america llc recall page.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1315-2026&limit=1
Keep browsing with these internal hubs: philips north america llc recall hub and Medical recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
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On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- February 18, 2026
- Source agency
- FDA
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