Spectral CT 7500 on Rails; Product Code (REF): 728334;
USSpectral CT 7500 on Rails; Product Code (REF): 728334;
Recalling Firm: Philips North America Llc
Reason for Recall / Hazard
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.
Product Description & Identification
Spectral CT 7500 on Rails; Product Code (REF): 728334;
Affected Products
Spectral CT 7500 on Rails; Product Code (REF): 728334;
Additional Source Details
| Field | Value |
|---|---|
| City | Cambridge |
| State | MA |
| Event id | 98248 |
| Address 1 | 222 Jacobs St |
| Address 2 | N/A |
| Code info | Product Code (REF): 728334; UDI-DI: 00884838103627; Serial Numbers: 1005, 1007, 1008; |
| Postal code | 02141-2289 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 3 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260107 |
| Initial firm notification | Letter |
| Center classification date | 20260206 |
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Overview
- Recalling FirmPhilips North America Llc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Macao, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkmenistan, United Kingdom, Uzbekistan, Vietnam.
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🚨 SAFETY ALERT: Philips North America Llc - Spectral CT 7500 on Rails; Product Code (REF): 728334; Check if your household is affected: https://therecallfile.com/recalls/spectral-ct-7500-on-rails-product-code-ref-728334/FDA-Z-1318-2026
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