Philips Achieva & Ingenia MR systems (2021-04-30)
- Starting date:
- April 30, 2021
- Posting date:
- May 13, 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-75571
Last updated:
2021-05-13
Affected Products
A. ACHIEVA 3.0T MRI SYSTEM-MAIN UNIT
B. ACHIEVA 1.5T MRI SYSTEM-MAIN UNIT
C. INGENIA 1.5T
D. INGENIA 3.0T
E. INGENIA 3.0T CX
F. INGENIA ELITION X
G. INGENIA AMBITION X
Reason
For the following MR systems manual in (or out) movement of the tabletop is not completely possible: Ingenia 1.5T, Ingenia 1.5T (s), Ingenia 1.5T CX, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition S, Ingenia Elition X, Smartpath to Dstream 1.5T, Smartpath to Dstream for XR and 3.0T.
The horizontal tabletop movement can be either motorized or in manual mode.
Manual mode means that the tabletop is moved manually by pushing or pulling the tabletop handgrip by the operator.
When the horizontal movement is in manual mode, the tabletop outward motion may be blocked while the table is only partly out of the bore. This is due to a mechanical failure (wrong gear profile). An unacceptable hazardous situation could occur, when the tabletop is in 'manual' mode during a quick evacuation of the patient from the MR system.
Affected products
A. ACHIEVA 3.0T MRI SYSTEM-MAIN UNIT
Lot or serial number
All lots.
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
All lots.
Model or catalog number
ACHIEVA 1.5T
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
C. INGENIA 1.5T
Lot or serial number
All lots.
Model or catalog number
1.5T
781315
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
D. INGENIA 3.0T
Lot or serial number
All lots.
Model or catalog number
3.0T
782103
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
E. INGENIA 3.0T CX
Lot or serial number
All lots.
Model or catalog number
781271
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
F. INGENIA ELITION X
Lot or serial number
All lots.
Model or catalog number
781358
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
G. INGENIA AMBITION X
Lot or serial number
All lots.
Model or catalog number
781356
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS