Philips North America Llc: Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

Hazard

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

Details from the source

Reason for recall: Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis. Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Poland, Portugal, Singapore, South Korea, Spain, S Quantity: 301 units Lot/code info: UDI-DI: (01)00884838101111. Software Version: 5.0.X. Model Number (Serial Numbers): 728333 (10266, 10261, 10264, 10219, 10265, 10197, 10182, 10175, 10192, 10179, 10196, 10180, 10188, 10190, 10181, 10183, 10178, 10186, 10185, 10199, 10184, 10198, 10193, 10187, 10189, 10195, 10191, 10194, 10018, 10023, 10027, 10062, 10072, 10078, 10079, 10080, 10084, 10088, 10101, 10104, 10112, 10117, 10113, 10116, 10032, 10049, 10133, 10140, 10152, 10153, 10166, 10170, 10171, 10173, 10172, 10174, 10016, 10015, 10017, 10019, 10022, 10021, 10020, 10025, 10024, 10033, 10031, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10043, 10042, 10014, 10044, 10046, 10048, 10045, 10047, 10051, 10050, 10053, 10055, 10052, 10056, 10058, 10057, 10059, 10060, 10061, 10065, 10066, 10068, 10067, 10070, 10071, 10063, 10069, 10074, 10075, 10077, 10076, 10081, 10082, 10087, 10089, 10085, 10086, 10091, 10094, 10093, 10095, 10096, 10090, 10099, 10098, 10102, 10100, 10103, 10097, 10105, 10106, 10107, 10108, 10109, 396001, 396003, 10110, 10111, 10114, 10115, 10122, 10118, 10120, 10121, 10123, 10119, 10124, 10125, 10126, 10127, 10129, 10128, 10131, 10130, 10132, 10135, 10136, 10134, 10137, 10139, 10138, 10142, 10141, 10143, 10144, 10145, 10146, 10147, 10149, 10150, 10151, 10155, 10156, 10159, 10148, 10160, 10161, 10162, 10158, 10164, 10163, 10165, 10167, 10168, 10169, 10013, 10177, 10176, 10210, 10218, 10217, 10206, 10202, 10200, 10211, 10207, 10204, 396004, 10208, 10201, 10205, 10203, 10212, 10213, 10225, 10214, 10220

UPC codes

00884838101111

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.