Health product recall

Uroskop Omnia, Uroskop Omnia Max (2019-02-07)

Starting date:
February 7, 2019
Posting date:
February 22, 2019
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-69116

Affected Products

  1. Uroskop Omnia
  2. Uroskop Omnia Max

Reason

Due to a manufacturing error of the monitor support arm, the swivel arm holding the monitors may become dislodged from the carrying arm. The probability of this issue occurrence will increase during the lifetime of the system.

Affected products

A. Uroskop Omnia

Lot or serial number
  • 3413
  • 3420
  • 3421
  • 3422
  • 3425
  • 3426
Model or catalog number
  • 10094910
Companies
Manufacturer

Siemens Healthcare GmbH

Henkestr. 127

Erlangen

91052

GERMANY

B. Uroskop Omnia Max

Lot or serial number
  • 4320
  • 4517
  • 4534
  • 4547
  • 4576
  • 4577
  • 4579
  • 4596
  • 4606
  • 4617
  • 4632
  • 5034
  • 5041
  • 5073
Model or catalog number
  • 10762473
Companies
Manufacturer

Siemens Healthcare GmbH

Henkestr. 127

Erlangen

91052

GERMANY