Gamma Sup Control System (2019-05-09)

Starting date:

May 9, 2019

Posting date:

August 30, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70831

Last updated: 2019-09-05

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  Reason
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  Affected products

Affected Products

1. Gamma Sup II - Control Unit
2. Gamma Sup II - CSI Probe

Reason

Currently, the parameterized Sup II gamma units with several probes are equipped with labels, on the unit's sealing strip, which indicate to the user on which isotope the probe was calibrated. Choosing the wrong isotope could result in a low count (reading) or no count. The probe can detect a bit less, but generally speaking, its count will be lower everywhere, including at injection sites. However, since the sentinel lymph node technique is a relative detection technique, this does not in any way hinder detection of the sentinel node; there will simply be a lower count on that node.

Affected products