Stealth Chamber

Starting date:

April 26, 2017

Posting date:

May 9, 2017

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-63292

• Reason
• Affected products

Reason

We have identified a potential safety issue related to the Stealth Chamber as a reference detector for water phantom measurements. When Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDS at shallow depth and geometric shadowing of measured profiles may appear.
Customer uses data acquired with stealth as reference chamber to commission treatment planning system (TPS), deviations in PDD for large fields and/or higher energies and/or distortions in profiles for large fields go unnoticed and the TPS accepts the data and is wrongly commissioned. Patients are treated with an inaccurate machine model for large fields. This might lead to mistreatment of patients.

Affected products