YSIO Max, Luminos DRF, Uroskop Omni Max, Luminos Agile Max (2020-01-17)

Starting date:

January 17, 2020

Posting date:

January 31, 2020

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-72241

Last updated: 2020-01-31

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  Reason
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  Affected products

Affected Products

1. YSIO Max
2. Luminos DRF Max
3. Uroskop Omni Max
4. Luminos Agile Max

Reason

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the ""override"" function, however, the user controls all system movements as the collision supervision functions are no longer active.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.

Affected products