Philips Medical Systems (Cleveland) Inc: 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.

Is my product affected?

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.

• UPC 00884838059474

Check against the official notice below — it lists the full affected range.

What happened

Philips Medical Systems is recalling 13 Brilliance iCT computed tomography systems used to produce images of the head and body. The recall affects units with serial numbers 100776 through 100794 (code 728306) distributed worldwide, including 4 units in the United States. Philips identified that certain fasteners on these systems cannot be confirmed to have been torqued to proper specifications, which could allow parts secured by the fasteners to become loose during use, potentially causing harm.

If fasteners were not torqued correctly and fail while the system is operating, loose parts may result. The source document does not specify a remedy or corrective action for affected consumers or healthcare facilities.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Philips has identified that 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, which may have a potential for harm.

Details from the source

Reason for recall: Philips has identified that 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, which may have a potential for harm. Distribution: Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts Quantity: 13 Lot/code info: 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, UDI: (01)00884838059474(21)100787; 100790, UDI: (01)00884838059474(21)100790; 100791, UDI: (01)00884838059474(21)100791; and 100794, UDI: (01)00884838059474(21)1007.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.2017-11-10
• MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be2017-11-10
• MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used w2017-11-10
• MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin in2017-11-10
• MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used wi2017-11-10

All FDA (Device enforcement) recalls