MultiDiagnost-ELEVA, OmniDiagnost Systems (2019-03-03)
- Starting date:
- March 3, 2019
- 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-69314
Affected Products
- Philips OmniDiagnost
- MultiDiagnost-ELEVA Intensifier - TV Image Dectector
- MultiDiagnost-ELEVA - Flat Detector - Image Detector
- MultiDiagnost-ELEVA - System
- OmniDiagnost ELEVA
Reason
For the height and tilt movement of the stand/table, the MultiDiagnost-ELEVA, OroDiagnost and OmniDiagnost systems have 2 actuators that are connected to the system stand by 4 shafts. The position of each of these shafts is secured by a locking plate.
During service of two MultiDiagnost-ELEVA systems, it was noticed that a locking plate was missing. In one of these cases, the shaft was still properly positioned after the system had been in use for 9 years. In the other case, involving a system that had been in use for 5 years, the shaft was no longer properly positioned but was still holding the actuator.
Over time, a missing locking plate may result in the shaft of the corresponding connection point becoming improperly positioned. If the shaft works its way totally out of position, it could result in unexpected stand/table tilt movement that cannot be stopped by the user.
Affected products
A. Philips OmniDiagnost
Lot or serial number
Not applicable.
Model or catalog number
OMNIDIAGNOST
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
B. MultiDiagnost-ELEVA Intensifier - TV Image Dectector
Lot or serial number
Not applicable.
Model or catalog number
0708MD02
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
C. MultiDiagnost-ELEVA - Flat Detector - Image Detector
Lot or serial number
Not applicable.
Model or catalog number
0708MD02
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
D. MultiDiagnost-ELEVA - System
Lot or serial number
Not applicable.
Model or catalog number
MRC 3011
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
E. OmniDiagnost ELEVA
Lot or serial number
Not applicable.
Model or catalog number
708027
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS