The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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: