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Health product recall

Enterprise 9000 Bed and Enterprise 8000 Bed

Starting date:
October 1, 2012
Posting date:
October 29, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-15134

Recalled Products:

  1. Enterprise 9000 Bed
  2. Enterprise 8000 Bed

Reason

Notice to customers with an additional warning to keep tubes and cables away from the patient's controls, and that failure to do so may lead to accidental operation of the control keys and inadvertent movement of the mattress platform. If such movement could injure the patient, use the function lockout to disable the controls when the patient is unattended.

Affected products

A. Enterprise 9000 Bed

Lot or serial number

More than 100 numbers, contact manufacturer

Model or catalog number
  • 9600BN62A12CC6
  • 9700BN82A12FC7
  • 9800BN12A12FC3
  • 9800BN62A11CC8
  • 9800BN62A12LC6
  • 9800BN82A11FU3
  • 9800BN82A12FC3
  • 9800BN82A12FC8
  • E9600
  • E9800
Companies
Manufacturer
Arjo Huntleigh Polska SP. Zoo

B. Enterprise 8000 Bed

Lot or serial number
  • 22575
  • 922658
  • P0104137
  • P085801
  • P085802
  • P085803
  • P085804
  • P085805
Model or catalog number
  • 8500BN82A11BU5
  • 8600BN22A11BC6
  • E8100
  • E8800
Companies
Manufacturer
Arjo Huntleigh Polska SP. Zoo