Health product recall

Philips CT System (Ingenuity, Iqon Spectral, Brilliance) (2021-05-07)

Starting date:
May 7, 2021
Posting date:
May 20, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75633

Last updated: 2021-05-20

Affected Products 

A. BRILLIANCE 40/64 SLICE CT SYSTEM
B. BRILLIANCE CT BIG BORE SYSTEM-MAIN UNIT
C. BRILLIANCE ICT SYSTEM-SYSTEM
D. BRILLIANCE ICT SP SYSTEM-MAIN
E. INGENUITY CT SYSTEM
F. IQON SPECTRAL CT

Reason

Philips has become aware of significant wear of the monitor bracket assembly shaft that goes unrecognized could potentially lead to the monitor bracket assembly detaching from the suspension arm.

Affected products

A. BRILLIANCE 40/64 SLICE CT SYSTEM

Lot or serial number

Not applicable.

Model or catalog number

728231

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS

B. BRILLIANCE CT BIG BORE SYSTEM-MAIN UNIT

Lot or serial number

Not applicable.

Model or catalog number

728244

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS

C. BRILLIANCE ICT SYSTEM-SYSTEM

Lot or serial number

Not applicable.

Model or catalog number

728306

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS

D. BRILLIANCE ICT SP SYSTEM-MAIN

Lot or serial number

Not applicable.

Model or catalog number

728311

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS

E. INGENUITY CT SYSTEM

Lot or serial number

Not applicable.

Model or catalog number

728326

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS

F. IQON SPECTRAL CT

Lot or serial number

Not applicable.

Model or catalog number

728332

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS