Health product recall

Ventri Nuclear Medicine System and Discovery NM 530c Nuclear Medicine System (2018-12-01)

Starting date:
December 1, 2018
Posting date:
January 8, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device, Biologic/vaccine
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68686

Affected products

  1. Ventri Nuclear Medicine System
  2. Discovery NM 530c Nuclear Medicine System

Reason

GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient's finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

The relevant software update, Field Action 40847, released in 2013, issued a mandatory software update to disable the automatic Unload motion feature. Requiring Unload table motions to be done manually (via Remote Control Unit) necessitates that the operator remain in close proximity to the patient during the Unload process. Appropriate operator monitoring while unloading the patient helps ensure that the patient arms and hands do not protrude from the table.

Affected products

A. Ventri Nuclear Medicine System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • H3000YT
Companies
Manufacturer
GE Medical Systems Israel
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL

B. Discovery NM 530c Nuclear Medicine System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • S8000RA
Companies
Manufacturer
GE Medical Systems Israel
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL