Reported Jan 24, 2024 · Ongoing
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
- Lot codes and dates
- 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.
- Amount recalled
- 197 units
Where it was sold
- Nationwide
Why it was recalled
Multiple software issues that affect device functionality.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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