Agency classClass IIOur severity:Severe FDA (Devices)·Z-1461-2014·Announced 2014-04-23

Philips CT Scanners Recalled for Defective Service Latch Component

Philips Medical Systems is recalling 135 CT scanners because a defective service latch component can cause the patient table top to become free-floating.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device that can cause the patient table to become free-floating, posing a significant risk of injury, which aligns with the 'Severe' criteria for structural defects and significant injury reports.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 135 Computed Tomography (CT) X-ray systems, including Brilliance and Ingenuity models, due to a manufacturing defect in the service latch assembly. The block assembly-lock stop subframe of the service latch was not manufactured to engineering specifications by the supplier, which can cause the threaded rod on the patient support service latch to fracture prematurely.

As a result of this defect, the table top can become free-floating due to the disengaged service latch in the table top's subframe. The affected units were distributed nationwide in the United States, including the states of California, Florida, Illinois, Indiana, Kentucky, Maryland, South Carolina, and Texas.

Healthcare facilities should contact Philips Medical Systems to arrange for the repair or replacement of the affected components. Consumers and patients should contact their healthcare provider if they have questions regarding the status of the equipment used for their imaging.

The recalled product

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.
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
fall-injury
Affected units: 135

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

See all →

High
Radiation planning software recalled over image errors in three patient orientations
FDA (Devices) · 2025-09-24
High
Pinnacle 3 radiation planning software may miscalculate stopping power ratio
FDA (Devices) · 2025-08-13
High
Pinnacle3 Radiation Therapy Planning System dose-calculation software error
FDA (Devices) · 2022-09-21
Severe
Philips Forte Gamma Camera System Recalled for Detector Fall Hazard
FDA (Devices) · 2019-11-13
Severe
Philips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
FDA (Devices) · 2019-11-13

Same hazard · structural defect