Z-1584-2023Class II

Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

Name: Z-1584-2023 Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Creator: Philips North America Llc
Published: 2023-03-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-03-17 / Open, Classified

FDA source

Philips North America Llc began a recall of Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 on 2023-03-17. FDA classified it as Class II and gives the reason as "Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1584-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-17
Posted: 2023-05-12
Recalling firm: Philips North America LLC
Product: Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.
FDA root cause: Under Investigation by firm
Action: An URGENT Medical Device Correction notification letter dated 3/17/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users Immediately stop using the Unload Pedal of the Foot Switch until Philips installs a solution on your system. Instead of using the Unload Pedal, please use the Unload Patient function on the Gantry Control Panels, or use other Table In/Out, Up/Down functions on the Gantry Control Panels, CT Scan Control Box, or Hardware Interventional Controls to fulfill the normal patient unloading function, as instructed in the IFU. You may continue to use Load Pedal, and Free-Float Pedal of Foot Switch, as they are not affected by this Urgent Medical Device Correction Letter. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 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 a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the solution to resolve this issue (refer to FCO72800795). Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 92 units
Distribution: Worldwide - US Nationwide distribution including in the states of States: AZ, IN, MA, MD, MN, NY, OH, PA, and TX. The countries of Australia, Austria, China, Czech Republic, Denmark, France, Germany, Israel, Japan, Malaysia, Netherlands, Norway, Palestine, Panama, South Korea, Spain, Switzerland, Thailand, United Kingdom.
Product codes and lots: UDI-DI: 00884838101111; Serial Numbers: 10058 10074 10080 10093 10096 10097 10098 10099 10100 10102 10103 10104 10105 10106 10107 10109 10110 10111 10114 10115 10117 10119 10123 396001 396003 10014 10015 10016 10017 10018 10019 10020 10021 10022 10023 10024 10025 10027 10031 10032 10033 10034 10035 10036 10038 10039 10040 10041 10042 10043 10044 10045 10046 10047 10048 10050 10051 10052 10053 10055 10056 10057 10059 10060 10061 10062 10063 10065 10066 10067 10068 10069 10070 10075 10076 10077 10081 10082 10085 10086 10087 10089 10090 10092 10094 10095 10108 10116 10120 10049 10121 10124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1584-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1584-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-12

Product code JAK

K203020Class IISpectral CTPhilips Medical Systems Nederland B.V. / cleared 2021-02-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)