Spectral CT 7500, Software Version 5.0.0.X. Computed… recallZ-0725-2024 · Philips North America Llc · initiated Nov 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Multiple software issues that affect device functionality.
FDA root cause category: Software design
What the company is doing
The recalling firm mailed consignees URGENT Medical Device Correction notifications dated 11/30/23. Consignees are asked to identify affected devices by their UDI-DI, of which affected devices are identified as having a UDI-DI of either 00884838101111 or 00884838111103, and a Product Code of either 728333 or 728340. Consignees may continue to use affected devices until a permanent solution is installed utilizing the precautions outlined in Table 2 of the notice. Consignees are asked to complete and return the provided response form no later than 30 days from receipt of the recall notification. Additionally, the recall notification is to be circulated among all users, so they are aware of the software issues. Philips will contact consignees to schedule a time for a field service engineer to visit your site and install the solution. Consignees with any questions or concerns are to contact Philips Customer Care Solutions Center at 1-800-722-9377.
Recall details
- Recall number
- Z-0725-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 30, 2023
- Posted by the FDA
- Jan 12, 2024
- Recalling firm
- Philips North America Llc
- Quantity
- 197 units
- Product code
- JAK
- FDA submissions
- K203020
- Distribution
- Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Panama, Palestine, Portugal, South Korea, Spain, Switzerland, Thailand, United Kingdom.
Product description
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Code information (models, lots, serial numbers)
Show the full code information (7k characters)
Model No. 728333 and 728340; Unique Device Identifier (UDI) (01)00884838101111(21)10148, (01)00884838101111(21)10158, (01)00884838101111(21)10160, (01)00884838101111(21)10162, (01)00884838101111(21)10163, (01)00884838101111(21)10165, (01)00884838101111(21)10166, (01)00884838101111(21)10167, (01)00884838111103(21)397002, (01)00884838111103(21)397003, (01)00884838111103(21)397004, (01)00884838111103(21)397005, (01)00884838111103(21)397006, (01)00884838111103(21)397007, (01)00884838111103(21)397008, (01)00884838111103(21)397009, (01)00884838111103(21)397010, (01)00884838111103(21)397011, (01)00884838111103(21)397013, (01)00884838111103(21)397014, (01)00884838111103(21)397015, (01)00884838101111(21)10021, (01)00884838101111(21)10034, (01)00884838101111(21)10035, (01)00884838101111(21)10036, (01)00884838101111(21)10038, (01)00884838101111(21)10039, (01)00884838101111(21)10042, (01)00884838101111(21)10048, (01)00884838101111(21)10049, (01)00884838101111(21)10052, (01)00884838101111(21)10055, (01)00884838101111(21)10057, (01)00884838101111(21)10067, (01)00884838101111(21)10068, (01)00884838101111(21)10069, (01)00884838101111(21)10081, (01)00884838101111(21)10082, (01)00884838101111(21)10085, (01)00884838101111(21)10087, (01)00884838101111(21)10088, (01)00884838101111(21)10089, (01)00884838101111(21)10091, (01)00884838101111(21)10092, (01)00884838101111(21)10093, (01)00884838101111(21)10096, (01)00884838101111(21)10098, (01)00884838101111(21)10100, (01)00884838101111(21)10102, (01)00884838101111(21)10103, (01)00884838101111(21)10104, (01)00884838101111(21)10105, (01)00884838101111(21)10106, (01)00884838101111(21)10107, (01)00884838101111(21)10108, (01)00884838101111(21)10109, (01)00884838101111(21)10111, (01)00884838101111(21)10112, (01)00884838101111(21)10113, (01)00884838101111(21)10116, (01)00884838101111(21)10119, (01)00884838101111(21)10120, (01)00884838101111(21)10125, (01)00884838101111(21)10126, (01)00884838101111(21)10127, (01)00884838101111(21)10128, (01)00884838101111(21)10131, (01)00884838101111(21)10132, (01)00884838101111(21)10133, (01)00884838101111(21)10134, (01)00884838101111(21)10136, (01)00884838101111(21)10137, (01)00884838101111(21)10138, (01)00884838101111(21)10140, (01)00884838101111(21)10141, (01)00884838101111(21)10142, (01)00884838101111(21)10143, (01)00884838101111(21)10144, (01)00884838101111(21)10145, (01)00884838101111(21)10147, (01)00884838101111(21)10149, (01)00884838101111(21)10151, (01)00884838101111(21)10152, (01)00884838101111(21)10168, (01)00884838101111(21)10171, (01)00884838111103(21)397016, (01)00884838111103(21)397019, (01)00884838111103(21)397018, (01)00884838111103(21)397017, (01)00884838111103(21)397020, (01)00884838111103(21)397021, (01)00884838101111(21)10182, (01)00884838101111(21)10173, (01)00884838101111(21)10174, (01)00884838111103(21)397022, (01)00884838101111(21)10186, (01)00884838111103(21)397024, (01)00884838111103(21)397025, (01)00884838101111(21)10187, (01)00884838111103(21)397027, (01)00884838111103(21)397028, (01)00884838101111(21)10193, (01)00884838101111(21)10155, (01)00884838101111(21)10156, (01)00884838101111(21)10159, (01)00884838101111(21)10161, (01)00884838101111(21)10164, (01)00884838111103(21)397012, (01)00884838101111(21)10013, (01)00884838101111(21)10014, (01)00884838101111(21)10015, (01)00884838101111(21)10016, (01)00884838101111(21)10017, (01)00884838101111(21)10018, (01)00884838101111(21)10019, (01)00884838101111(21)10020, (01)00884838101111(21)10022, (01)00884838101111(21)10023, (01)00884838101111(21)10024, (01)00884838101111(21)10025, (01)00884838101111(21)10031, (01)00884838101111(21)10032, (01)00884838101111(21)10033, (01)00884838101111(21)10040, (01)00884838101111(21)10041, (01)00884838101111(21)10043, (01)00884838101111(21)10044, (01)00884838101111(21)10045, (01)00884838101111(21)10046, (01)00884838101111(21)10047, (01)00884838101111(21)10050, (01)00884838101111(21)10051, (01)00884838101111(21)10053, (01)00884838101111(21)10056, (01)00884838101111(21)10058.(01)00884838101111(21)10059, (01)00884838101111(21)10060, (01)00884838101111(21)10061, (01)00884838101111(21)10062, (01)00884838101111(21)10063, (01)00884838101111(21)10065, (01)00884838101111(21)10066, (01)00884838101111(21)10070, (01)00884838101111(21)10071, (01)00884838101111(21)10072, (01)00884838101111(21)10074, (01)00884838101111(21)10075, (01)00884838101111(21)10076, (01)00884838101111(21)10077, (01)00884838101111(21)10078, (01)00884838101111(21)10079, (01)00884838101111(21)10080, (01)00884838101111(21)10084, (01)00884838101111(21)10086, (01)00884838101111(21)10090, (01)00884838101111(21)10094, (01)00884838101111(21)10095, (01)00884838101111(21)10097, (01)00884838101111(21)10099, (01)00884838101111(21)10101, (01)00884838101111(21)10110, (01)00884838101111(21)10114, (01)00884838101111(21)10115, (01)00884838101111(21)10117, (01)00884838101111(21)10118, (01)00884838101111(21)10121, (01)00884838101111(21)10122, (01)00884838101111(21)10123, (01)00884838101111(21)10124, (01)00884838101111(21)10129, (01)00884838101111(21)10130, (01)00884838101111(21)10135, (01)00884838101111(21)10139, (01)00884838101111(21)10146, (01)00884838101111(21)10150, (01)00884838101111(21)10153, (01)00884838101111(21)396001, (01)00884838101111(21)396003, (01)00884838101111(21)10170, (01)00884838101111(21)10169, (01)00884838101111(21)10172, (01)00884838101111(21)10177, (01)00884838101111(21)10179, (01)00884838111103(21)397023, (01)00884838101111(21)10176, (01)00884838101111(21)10178, (01)00884838101111(21)10184, (01)00884838101111(21)10183, (01)00884838101111(21)10180, (01)00884838101111(21)10181, (01)00884838101111(21)10185, (01)00884838101111(21)10188, (01)00884838101111(21)10191, (01)00884838101111(21)10190, (01)00884838101111(21)10192, (01)00884838101111(21)10175, (01)00884838101111(21)10189; Serial No. 10148, 10158, 10160, 10162, 10163, 10165, 10166, 10167, 397002, 397003, 397004, 397005, 397006, 397007, 397008, 397009, 397010, 397011, 397013, 397014, 397015, 10021, 10034, 10035, 10036, 10038, 10039, 10042, 10048, 10049, 10052, 10055, 10057, 10067, 10068, 10069, 10081, 10082, 10085, 10087, 10088, 10089, 10091, 10092, 10093, 10096, 10098, 10100, 10102, 10103, 10104, 10105, 10106, 10107, 10108, 10109, 10111, 10112, 10113, 10116, 10119, 10120, 10125, 10126, 10127, 10128, 10131, 10132, 10133, 10134, 10136, 10137, 10138, 10140, 10141, 10142, 10143, 10144, 10145, 10147, 10149, 10151, 10152, 10168, 10171, 397016, 397019, 397018, 397017, 397020, 397021, 10182, 10173, 10174, 397022, 10186, 397024, 397025, 10187, 397027, 397028, 10193, 10155, 10156, 10159, 10161, 10164, 397012, 10013, 10014, 10015, 10016, 10017, 10018, 10019, 10020, 10022, 10023, 10024, 10025, 10031, 10032, 10033, 10040, 10041, 10043, 10044, 10045, 10046, 10047, 10050, 10051, 10053, 10056, 10058, 10059, 10060, 10061, 10062, 10063, 10065, 10066, 10070, 10071, 10072, 10074, 10075, 10076, 10077, 10078, 10079, 10080, 10084, 10086, 10090, 10094, 10095, 10097, 10099, 10101, 10110, 10114, 10115, 10117, 10118, 10121, 10122, 10123, 10124, 10129, 10130, 10135, 10139, 10146, 10150, 10153, 396001, 396003, 10170, 10169, 10172, 10177, 10179, 397023, 10176, 10178, 10184, 10183, 10180, 10181, 10185, 10188, 10191, 10190, 10192, 10175, 10189.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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