Z-1461-2014Class II

Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology...

Name: Z-1461-2014 Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2014-03-27
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-03-27 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity... on 2014-03-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1461-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-27
Posted: 2014-04-16
Terminated: 2016-02-02
Recalling firm: Philips North America LLC
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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 135
Distribution: Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1461-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1461-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)