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Health product recall

Wireless X-ray FSW Mono/Biplane/Mono-MP (2017-09-26)

Starting date:
September 26, 2017
Posting date:
October 13, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-64838

Affected products

  1. WIRELESS XRAY FSW MONO
  2. WIRELESS XRAY FSW BIPLANE
  3. WIRELESS XRAY FSW MONO-MP

Reason

The Wireless Footswitch can fail due to impacts by external factors, such as electrostatic discharge that exceeds a certain intensity. Troubleshooting actions have been implemented (resetting the affected assembly) but have no effect in this case.

Affected products

A. WIRELESS XRAY FSW MONO

Lot or serial number

Not Appicable

Model or catalog number

4787797

Companies
Manufacturer

Siemens Healthcare GMBH

HENKESTRASSE 127

ERLANGEN

91052

GERMANY



B. WIRELESS XRAY FSW BIPLANE

Lot or serial number

Not Appicable

Model or catalog number

4787805

Companies
Manufacturer

Siemens Healthcare GMBH

HENKESTRASSE 127

ERLANGEN

91052

GERMANY



C. WIRELESS XRAY FSW MONO-MP

Lot or serial number

Not Appicable

Model or catalog number

4787813

Companies
Manufacturer

Siemens Healthcare GMBH

HENKESTRASSE 127

ERLANGEN

91052

GERMANY