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Health product recall

MR SURGICAL SUITE II TABLE (2015-10-29)

Starting date:
October 29, 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-55856

Affected Products

MR SURGICAL SUITE II TABLE

Reason

Potential safety issue with the table transfer release of the MR SURGICAL SUITE II MR System. The issue may cause an unexpected function loss of the patient transfer mechanism that allows the patient to be moved between the MR and surgical tables. This could delay care and handling of a patient during surgical or interventional procedures. GE has received one complaint of a transfer board not releasing from the MR table preventing the transfer board from moving to the surgical table. There have been no injuries reported as a result of this issue.

Affected products

MR SURGICAL SUITE II TABLE

Lot or serial number

416369MR3T

Model or catalog number

M0001SS

Companies
Manufacturer
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES