FDAFDA · Food and drugs·Recall number Z-0725-2024
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Published January 24, 2024 · Recall initiated: November 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Multiple software issues that affect device functionality.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- 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.
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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