—#126466

Product

Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009, K033326, K033357, K060937
Affected lot / code info: Brilliance CT 16: Model Number: 728246; Serial Number: 5314, 6719, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6734, 6735, 6736, 6737, 6738, 6744, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6764, 6767, 6768, 6772, and 50213. Brilliance CT 64: Model Number: 728231; Serial Number: 10805, 10806, 90047, 95880, 95881, 95882, 95885, 95892, 95903, 95907, 95910, 95912, 95913, 95914, 95915, 95918, 95920, 95921, 95922, and 98895. Brilliance CT Big Bore Oncology: Model Number: 728243; Serial Number: 7971, 7977, 7980, 7989, and 7994. Brilliance CT Big Bore Radiology: Model Number: 728244; Serial Number: 7957, 7965, 7979, and 7985. Brilliance iCT: Model Number: 728306; Serial Number: 100477, 100483, 100487, 100489, 100491, 100492, 100494, 100495, 100496, 100500, 100502, 100504, and 100507. Ingenuity CT: Model Number: 728326; Serial Number: 300165 and 333013. Ingenuity Core: Model Number: 728321; Serial Number: 310138, 310142, 310144, 310145, 310149, 310151, 310152, 310153, 310154, 310155, 310158, 310160, 310161, 310162, 310163, 310164, 333013, 333015, and 333017. Ingenuity Core128: Model Number: 728323; Serial Number: 320113, 320114, 320116, 320117, 320118, 320120, 320121, 320122, 320124, 320125, 320128,320129, 320130, 320134, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144,320145, 320146, 320147, 320148, 336009, 336010, 336011, 336012, 336013, 336015, 336016, 336018, and 336023. Ingenuity Flex: Model Number: 728317; Serial Number: 345005

Why it was recalled

Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

A Field Safety Notice was sent to all US consignees via certified mail. Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX.

Timeline

Recall initiated: 2014-03-27
Posted by FDA: 2014-04-16
Terminated: 2016-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126466. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.