Philips OmniDiagnost and OmniDiagnost Eleva (2018-05-07)
- Starting date:
- May 7, 2018
- Posting date:
- May 18, 2018
- 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-66816
Affected products
A. PHILIPS OMNIDIAGNOST
B. OMNIDIAGNOST ELEVA
Reason
Philips has been reported instances in which the table of the OmniDiagnost system (OD-Eleva) suddenly started to rotate from 0 to 90 degree (table arm down) with high speed. The cause of this unexpected rotation movement is related to an issue with the fixation of the upper and lower tilt actuator. If the system rotates uncontrolled, there is a risk of injury for the patient on the table. A rotating table also might hit the user or bystander standing near the system.
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. 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