Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1. Model Number: 728306; UDI-DI: 00884838059474; Serial Number: 100068, 100188, 100241, 100288, 100332, 100365, 100461, 85007, 85016, 100657, 100682, 100686, 100779, 100832, 100783, 100775, 100788, 100807, 100828, 100816, 85136, 85153, 100043, 100038, 100082, 100074, 100081, 100097, 100098, 100119, 100111, 100113, 100123, 100130, 100133, 100222, 100141, 100134, 100160, 100157, 100150, 100158, 100180, 100161, 100173, 100215, 100064, 100117, 100247, 100172, 100196, 200045, 100191, 100374, 100189, 100230, 100203, 100201, 100204, 100211, 100234, 100227, 100249, 100285, 100245, 100253, 100226, 100264, 100292, 100268, 100294, 100302, 100315, 100301, 100310, 100336, 100314, 100349, 100354, 100321, 100389, 100385, 100446, 100424, 100401, 100352, 100404, 100511, 100412, 100438, 100435, 100455, 100380, 100487, 100429, 100427, 100443, 100393, 100413, 100462, 100604, 100456, 100497, 100498, 100502, 100500, 100445, 100510, 100505, 100513, 100635, 85018, 85014, 100612, 85041, 100603, 85035, 85028, 100669, 100622, 100627, 85065, 100631, 100601, 100663, 85053, 100656, 85062, 100708, 100685, 85057, 85061, 100677, 100653, 100673, 100707, 100672, 100691, 100683, 100678, 100687, 100718, 100717, 85069, 100698, 100695, 100704, 100769, 85058, 100712, 100711, 100744, 100800, 100735, 100734, 100727, 100745, 100851, 100763, 100766, 100770, 85104, 100780, 100784, 85129, 100840, 100794, 100797, 100815, 100829, 85087, 100809, 85082, 100821, 100814, 100836, 100834, 100837, 100831, 85121, 85124, 85169, 85118, 85127, 85142, 85147, 85144, 85196, 85233, 85265, 85180, 85173, 85202, 87013, 85189, 85200, 85243, 85211, 85221, 85217, 85215, 85236, 87004, 85249, 85276, 87015, 87037, 87031, 87045, 87211.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips North America Llc
- Reason for Recall:
- The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Product Codes/Lot Numbers:
1. Model Number: 728306; UDI-DI: 00884838059474; Serial Number: 100068, 100188, 100241, 100288, 100332, 100365, 100461, 85007, 85016, 100657, 100682, 100686, 100779, 100832, 100783, 100775, 100788, 100807, 100828, 100816, 85136, 85153, 100043, 100038, 100082, 100074, 100081, 100097, 100098, 100119, 100111, 100113, 100123, 100130, 100133, 100222, 100141, 100134, 100160, 100157, 100150, 100158, 100180, 100161, 100173, 100215, 100064, 100117, 100247, 100172, 100196, 200045, 100191, 100374, 100189, 100230, 100203, 100201, 100204, 100211, 100234, 100227, 100249, 100285, 100245, 100253, 100226, 100264, 100292, 100268, 100294, 100302, 100315, 100301, 100310, 100336, 100314, 100349, 100354, 100321, 100389, 100385, 100446, 100424, 100401, 100352, 100404, 100511, 100412, 100438, 100435, 100455, 100380, 100487, 100429, 100427, 100443, 100393, 100413, 100462, 100604, 100456, 100497, 100498, 100502, 100500, 100445, 100510, 100505, 100513, 100635, 85018, 85014, 100612, 85041, 100603, 85035, 85028, 100669, 100622, 100627, 85065, 100631, 100601, 100663, 85053, 100656, 85062, 100708, 100685, 85057, 85061, 100677, 100653, 100673, 100707, 100672, 100691, 100683, 100678, 100687, 100718, 100717, 85069, 100698, 100695, 100704, 100769, 85058, 100712, 100711, 100744, 100800, 100735, 100734, 100727, 100745, 100851, 100763, 100766, 100770, 85104, 100780, 100784, 85129, 100840, 100794, 100797, 100815, 100829, 85087, 100809, 85082, 100821, 100814, 100836, 100834, 100837, 100831, 85121, 85124, 85169, 85118, 85127, 85142, 85147, 85144, 85196, 85233, 85265, 85180, 85173, 85202, 87013, 85189, 85200, 85243, 85211, 85221, 85217, 85215, 85236, 87004, 85249, 85276, 87015, 87037, 87031, 87045, 87211.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2598-2025
Related Recalls
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Philips North America
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
IntelliVue MP90. Product Number: M8010A.
Philips North America
Potential issue where the IntelliVue monitors did not alarm.
IntelliVue MP30. Product Number: M8002A.
Philips North America
Potential issue where the IntelliVue monitors did not alarm.