FDA Medical devices recall ·
Spectral CT and Spectral CT Plus recall
- Recall number
- Z-0583-2025
- Date
- (initiated November 16, 2024)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 301 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.
States: Arkansas Arizona California Florida Georgia Hawaii Indiana Kentucky Massachusetts Maryland Minnesota New York Ohio Oregon Pennsylvania Texas Vermont Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0583-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.