Reported May 23, 2018 · Terminated
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in…
Visaris DOO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Visaris DOO · Batajnicki Drum 10 Deo 1B · Belgrade · N/A
Is this the product you have?
- 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
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 System SN VC17J-02002, Column SN BA-215-1800-862-1-3 0019 2 System SN VC17F-01002, Column SN BA-215-1800-862-1-3 0035 3 System SN VC17C-01002, Column SN BA-215-1800-862-1-3 0031 4 International Systems: System SN VC17J-02002, Column SN BA-215-1800-862-1-3 0034 5 System SN VC17I-01002, Column SN BA-215-1500-792-1 0016 6 System SN VC17G-02002, Column SN BA-215-1800-862-1-3 0023 7 System SN VC16K-01002, Column SN BA-215-1800-862-1-3 0032 - Amount recalled
- 8 devices (US), 14 devices (international)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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