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Health product recall

Ultraview SL2600,SL Compact Monitor and SL Bedside/Central Monitor (2014-09-18)

Starting date:
September 18, 2014
Posting date:
September 22, 2014
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-41437

Recalled products

  1. Ultraview SL2600 Compact Monitor
  2. Ultraview SL Compact Monitor
  3. Ultraview SL Bedside/Central Monitor

Reason

Potential hazard associated with the use of all patient monitors equipped with the perioperative option (-D). Operating room staff may not be aware that alarm tones are off if the device has been left in the end case state. This is more likely to occur in emergency surgery situations and with surgical teams that are not familiar with the monitor's operation.

Affected products

A. Ultraview SL2600 Compact Monitor

Lot or serial number
  • 1370-004133
Model or catalog number
  • 91370
Companies
Manufacturer
Spacelabs Healthcare Inc.
35301 SE Center Street
Snoqualmie
98065
Washington
UNITED STATES

B. Ultraview SL Compact Monitor

Lot or serial number
  • 1369-007338
Model or catalog number
  • 91369
Companies
Manufacturer
Spacelabs Healthcare Inc.
35301 SE Center Street
Snoqualmie
98065
Washington
UNITED STATES

C. Ultraview SL Bedside/Central Monitor

Lot or serial number
  • 1387-005006
  • 1387-102371
  • 1387-102372
  • 1387-102373
Model or catalog number
  • 91387
Companies
Manufacturer
Spacelabs Healthcare Inc.
35301 SE Center Street
Snoqualmie
98065
Washington
UNITED STATES