Recalls / —

—#205001

Product

Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K203020

Affected lot / code info

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.

Why it was recalled

Multiple software issues that affect device functionality.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Philips North America Llc

Address

222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2023-11-30

Posted by FDA

2024-01-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #205001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.