Uroskop Omnia & Uroskop Omnia Max (2020-09-11)

Starting date:

September 11, 2020

Posting date:

October 2, 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-74043

Last updated:
2020-10-01

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  Reason
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  Affected products

Affected Products

1. Uroskop Omnia
2. Uroskop Omnia Max

Reason

Potential issue and possible hazard during patient positioning associated with the monitor support arm (model # 10999410) on the Uroskop Omnia and Uroskop Omnia Max urological systems. Siemens released a corrective action and successfully implemented it via an update with internal ID # XP006/19/S (Incident No. 174383). However, a residual improbable risk of the support arm becoming dislodged remained in rare cases when the monitor support arm is used intensely over a long period of time.

Affected products