Product Wiki · Recalls · Health Canada — Medical Devices

YSIO Max, Luminos DRF, Uroskop Omni Max, Luminos Agile Max… — recall 63121

Health Canada — Medical Devices · Canada · 2020-01-31 · Type II

As described by Health Canada — Medical Devices: YSIO Max, Luminos DRF, Uroskop Omni Max, Luminos Agile Max (2020-01-17)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
63121
Date of alert
2020-01-31
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens is notifying users of two potentially hazardous issues and a software update intended to correct these issues. The potential hazards are two separate issues; however, they will be addressed with the same software update. Issue # 1: Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems. The potential exists for a system collision due to incorrect use of the bypass key overriding the built-in collision control. The bypass key is intended to enable movement of an otherwise blocked system to avert immediate hazard, e.g. to recover a patient following device error or in case of emergency. It is not intended for permanent use. During the use of the bypass key, the system regains movement using the ""override"" function, however, the user controls all system movements as the collision supervision functions are no longer active. There is a risk of collision with obstacles or persons when the operator uses the override function. Issue # 2: Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static The potential exists for one image to be assigned to two different patients. In the unlikely event of an interrupted connection to a MAX Static detector during patient examination, a previously acquired image (possibly belonging to the previous patient) could be duplicated and stored in the current patient's data set.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ysio-max-luminos-drf-uroskop-o

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