The Recall Desk
HighFDA (Devices)·Z-0388-2018·Announced 2018-01-24

Philips Brilliance iCT Recalled for Potential Fastener Torque Defect

Philips is recalling 13 Brilliance iCT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for potential mechanical failure in a medical device.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 13 units of the Brilliance iCT medical device. The device is intended to produce images of the head and body by computer reconstruction of x-ray transmission data. The recall is due to a manufacturing issue where certain fasteners cannot be confirmed to have been torqued according to specification.

If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose. This condition has a potential for harm to patients or operators. The affected units were distributed worldwide, including in the United States, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. In the US, 4 units were affected, including one military account, while 14 foreign accounts were involved.

Healthcare facilities and users should stop using the affected Brilliance iCT units and contact Philips Medical Systems for further instructions on repair or replacement. The specific serial numbers and UDI codes for the affected units are listed in the official recall documentation.

The recalled product

Product
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
13

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)

  • Code 728306
  • SN# 100776
  • UDI: (01)00884838059474(21)100776
  • 100778
  • UDI: (01)00884838059474(21)100778
  • 100779
  • UDI: (01)00884838059474(21)100779
  • 100780
  • UDI: (01)00884838059474(21)100780
  • 100781
  • UDI: (01)00884838059474(21)100781
  • 100782
  • UDI: (01)00884838059474(21)100782
  • 100783
  • UDI: (01)00884838059474(21)100783
  • 100784
  • UDI: (01)00884838059474(21)100784
  • 100785
  • UDI: (01)00884838059474(21)100785
  • 100787

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

See all →

Same hazard · mechanical failure

See all →