Visaris Vision/Auto — Class II medical device recall Z-1880-2018
Terminated recall by Visaris DOO, reported 2018-05-23, distributed in FL, LA, MD, MS, NJ, NY. A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube heig
| Recall number | Z-1880-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Visaris DOO, Belgrade |
| Recall initiated | 2018-04-05 |
| Classified | 2018-05-15 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2019-09-19 |
| Distributed | FL, LA, MD, MS, NJ, NY |
| Countries outside the US | CH, CZ, DE, GB, RS, TW |
Product
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 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
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.