Achieva 1.5T, 3.0T, XR MRI Systems, Intera 1.5T, 3.0T MRI Systems, Ingenia 1.5T, 3.0T, 3.0T CX, Ingenia Elition X, and Panorama HFO (2018-12-17)
- Starting date:
- December 17, 2018
- Posting date:
- March 15, 2019
- 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-69320
Affected Products
- Achieva 3.0T MRI System - Main Unit
- Achieva 1.5T MRI System - Main Unit
- Achieva XR System - Main Unit
- Panorama HFO
- Intera 1.5T MRI System - Main Unit
- Intera 3.0T MRI System
- Ingenia 1.5T
- Ingenia 3.0T
- Ingenia 3.0T CX
- Ingenia Elition X
Reason
Philips MR systems are standard equipped with two ceiling speakers, positioned in the front and/or rear of the MR system. These speakers enable communication between the operator in the examination room and the patient and offer stereo music or ambient experience audio. These speakers are in most cases fixated in the suspended ceiling of the MR examination room according the Philips service instructions. The Philips Planning Reference Data (PRD) prescribes the suspended ceiling must be strong enough to hold 25 N speakers.
However in very rare cases, due to external influences (hospital facility maintenance, water leakage, degradation of speaker fixation) during the lifetime of the MR system, the ceiling speaker(s) could fall from their position and be pulled to the MR system by the magnetic field.
Affected products
A. Achieva 3.0T MRI System - Main Unit
Lot or serial number
Not applicable.
Model or catalog number
ACHIEVA 3.0T
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
B. Achieva 1.5T MRI System - Main Unit
Lot or serial number
Not applicable.
Model or catalog number
ACHIEVA 1.5T
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
C. Achieva XR System - Main Unit
Lot or serial number
Not applicable.
Model or catalog number
ACHIEVA XR
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
D. Panorama HFO
Lot or serial number
Not applicable.
Model or catalog number
PANORAMA HFO
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
E. Intera 1.5T MRI System - Main Unit
Lot or serial number
Not applicable.
Model or catalog number
INTERA 1.5T
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
F. Intera 3.0T MRI System
Lot or serial number
Not applicable.
Model or catalog number
INTERA 3.0T
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
G. Ingenia 1.5T
Lot or serial number
Not applicable.
Model or catalog number
1.5T
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
H. Ingenia 3.0T
Lot or serial number
Not applicable.
Model or catalog number
3.0T
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
I. Ingenia 3.0T CX
Lot or serial number
Not applicable.
Model or catalog number
781271
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
J. Ingenia Elition X
Lot or serial number
Not applicable.
Model or catalog number
781358
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS