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Health product recall

SwitchPoint Infinity 3 Control System (2014-09-11)

Starting date:
September 11, 2014
Posting date:
September 16, 2014
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-41385

Recalled products

  1. SwitchPoint Infinity 3 Control System

Reason

Stryker has become aware that there is a likelihood of audio loss, intermittent audio, or distorted audio with the SwitchPoint Infinity3 (SPI 3). The non-conformance was identified due to the increasing trend in the number of SPI 3 audio board replacements.

Affected products

A. SwitchPoint Infinity 3 Control System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 0678-001-000
Companies
Manufacturer
Stryker Communications
1410 Lakeside Pkwy #100
Flower Mound
75028
Texas
UNITED STATES