Health product recall

IMRIS Operating Room Tables (T2X, ORT100, ORT300) (2018-10-25)

Starting date:
September 25, 2018
Posting date:
March 1, 2019
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-69170

Affected Products

  1. IMRIS Operating Room Table Model T2X
  2. IMRIS Operating Room Table Model ORT100
  3. IMRIS Operating Room Table Model ORT300

Reason

The roll cylinders in the Operating Room Tables contain an O-ring seal that may degrade over time and may cause drift in the table while in use. This could potentially result in unintended movement of the table which may pose a risk of injury to the patient.

Affected products

  1. IMRIS Operating Room Table Model T2X

Lot or serial number

10001305

Model or catalog number

109682-600
 

Companies
Manufacturer
Deerfield Imaging, Inc.
5101 Shady Oak Road
Minnetonka
55343
Minnesota
UNITED STATES

B. IMRIS Operating Room Table Model ORT100

Lot or serial number

10002607
10002848

Model or catalog number

110470-000

Companies
Manufacturer
Deerfield Imaging, Inc.
5101 Shady Oak Road
Minnetonka
55343
Minnesota
UNITED STATES

C. IMRIS Operating Room Table Model ORT300

Lot or serial number

10002385
10004515

Model or catalog number

114093-000

Companies
Manufacturer
Deerfield Imaging, Inc.
5101 Shady Oak Road
Minnetonka
55343
Minnesota
UNITED STATES