Ultraview SL Command Module (2015-05-06)

Starting date:

May 6, 2015

Posting date:

June 3, 2015

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-53623

• Reason
• Affected products

Recalled Products

A. Ultraview SL Command Module

Reason

Potential hazard associated with the use of the Spacelabs Medical Ultraview SL Command Module with the Masimo SpO2 PCBA, PN: 010-1636- 02. The reset sequence takes approximately 10 seconds and during this period monitoring of all parameters will be suspended. Upon completion of the reset sequence, all alarm limits will be reset to their site-defined default values. Critical alarms for ventricular fibrillation and asystole are always enabled after the reset. If invasive pressure is being monitored, labels will be reset to default values and the zero calibration will be lost. If non-invasive pressure is being monitored, the automatic measurement mode will be disabled. A separate failure mode can also occur where the SpO2 menu keys become unresponsive and prevent user changes to SpO2 operation and alarm settings. In this state, all alarm limits, alarm functions and parameter monitoring continue unaffected and all alarm limits other than SpO2 can still be adjusted.

Affected products