Health product recall

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