Visaris DOO: Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

Recall number

Z-1882-2018

Recalling firm

Visaris DOO

Product

Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

Status

Terminated

Initiated

2018-04-05

Posted

not on file

Terminated

2019-09-19

Reason

A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube height adjustment there is a small probability of failure of both the primary and redundant holding mechanisms, causing uncontrollable descent of the tube arm and a potential risk of injury to the patient.

Root cause

Other

Action

Notification letters instruct users to perform the following actions: System end users should: Sign and return the Acknowledgement Form (part of this document). allow Visaris authorized service engineers access to perform the scheduled upgrade and refresher user training Read and familiarize themselves with the current user manual for Vision C devices and safety guidelines provided therein. Within the next four weeks Visaris will prepare and deliver an improved version of the elevation column mechanism for the Vision C devices to all relevant authorized distributors and service organizations. Visaris distributors will get in touch with you to initiate and agree a schedule of the field upgrade. Visaris engineers will at scheduled times upgrade the column mechanisms, including complete site acceptance and additional safety testing on all upgraded devices. During this activity users will be provided with the latest version of user manual and re-fresher system use training. This notice and relevant end user action information needs to be passed on to all system end user organizations. Please acknowledge receipt of this notification and maintain awareness of this notice and resulting actions for a period of three months to ensure effectiveness of the upgrade actions. For further questions, please call (239) 234-1735.

Quantity

8 devices (US), 14 devices (international)

Distribution

Worldwide Distribution - US Distribution to the states of : FL, LA, MD, MS, NJ, and NY., and to the countries of : Czech Republic, Germany, Serbia, Switzerland, Taiwan, and United Kingdom.

Lot, serial or model codes

US Systems: System SN VC17J-02002, Column SN BA-215-1800-862-1-3 0019; System SN VC17F-01002, Column SN BA-215-1800-862-1-3 0035; System SN VC17C-01002, Column SN BA-215-1800-862-1-3 0031;   International Systems: System SN VC17J-02002, Column SN BA-215-1800-862-1-3 0034; System SN VC17I-01002, Column SN BA-215-1500-792-1 0016; System SN VC17G-02002, Column SN BA-215-1800-862-1-3 0023; System SN VC16K-01002, Column SN BA-215-1800-862-1-3 0032;

510(k) numbers

["K160620"]

PMA numbers

not on file

Product code

KPR

Firm FEI

3012569470

Firm city

Belgrade

Firm state

not on file

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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