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Health product recall

ULTRAVIEW SL COMMAND MODULE (2016-07-08)

Starting date:
July 8, 2016
Posting date:
July 29, 2016
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-59604

Affected products

A. ULTRAVIEW SL COMMAND MODULE

Reason

Spacelabs has received multiple reports of the Non-invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (no reading). In addition, there is one of the following three error messages: inflate error, hw error, or no data. Spacelabs is not aware of any injuries related to this issue

Affected products

A. ULTRAVIEW SL COMMAND MODULE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

91496

Companies
Manufacturer
Spacelabs Healthcare Inc.
35301 SE Center Street
Snoqualmie
98065
UNITED STATES