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Health product recall

Imex Elite 100 and 200 Doppler (2017-06-12)

Starting date:
June 12, 2017
Posting date:
July 6, 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-63844

Affected Products

A. Imex Elite 100 Doppler

B. Imex Elite 200 Doppler

Reason

Natus has discovered that some of the Elite 2 and 3 obstetric probes and 5 MHZ vascular probes may exhibit excessive background noise that may mask the user's ability to clearly hear heart rate and/or blood flow.

Affected products

A. Imex Elite 100 Doppler

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

N300

N500

NW20

Companies
Manufacturer

Natus Neurology Incorporated

3150 Pleasant View Road

Middleton

53562

UNITED STATES



B. Imex Elite 200 Doppler

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

N300

N500

NW20

Companies
Manufacturer

Natus Neurology Incorporated

3150 Pleasant View Road

Middleton

53562

UNITED STATES