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
- Ventri Nuclear Medicine System
- 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