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Health product recall

MobileDiagnost wDR, REL. 2

Starting date:
December 29, 2016
Posting date:
January 18, 2017
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-61840

Reason

When the operator connects the unit to the mains using a non-hospital-grade mains outlet, the protective earth connection may not be effective and an electrical defect inside the unit could cause a dangerous voltage to be present on the housing. The operator may not be aware of such danger, when the "Hospital grade mains connector required" warning label is missing, which must be present in Canada according to local electrical codes.

Affected products

MobileDiagnost wDR, REL. 2

Lot or serial number

MobileDiagnost wDR, Rel. 2
in Canada

Model or catalog number

9890 010 8952X

Companies

Manufacturer
Philips Medical Systems Dmc Gmbh
Rontgenstrabe 24
Hamburg
22335
GERMANY