Z-1318-2026Class II

Spectral CT 7500 on Rails; Product Code (REF): 728334

Name: Z-1318-2026 Spectral CT 7500 on Rails; Product Code (REF): 728334
Creator: Philips North America Llc
Published: 2026-01-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2026-01-07 / Open, Classified

FDA source

Philips North America Llc began a recall of Spectral CT 7500 on Rails; Product Code (REF): 728334 on 2026-01-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1318-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-07
Posted: 2026-02-06
Recalling firm: Philips North America LLC
Product: Spectral CT 7500 on Rails; Product Code (REF): 728334;
Product code: JAK System, X-Ray, Tomography, Computed
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.
FDA root cause: Process change control
Action: On or about January 7, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. As a precaution, monitor the gantry for any unusual sounds or vibrations during operation. If unusual sounds are heard or vibrations are observed, immediately call your service contact. In the absence of unusual sounds or vibrations, you may continue to use your system(s) according to the intended use. 2. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until Philips has inspected your system and has provided any correction, if needed. Ensure the letter is in a place likely to be seen and read. Actions planned by Philips: Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and to inspect the fasteners on your system (reference FCO72800845). If the inspection indicates that your system is affected, Philips will perform the correction to resolve the issue (reference FCO72800846)
Quantity in commerce: 3 units
Distribution: Worldwide - 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.
Product codes and lots: Product Code (REF): 728334; UDI-DI: 00884838103627; Serial Numbers: 1005, 1007, 1008;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1318-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1315-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1316-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1317-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1318-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06

Product code JAK

K212875Class IISpectral CT on RailsPhilips Medical Systems Nederland B.V. / cleared 2022-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)