CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Visaris Vision/Auto, ddRAura recalled by Visaris DOO
Visaris DOO is recalling Visaris Vision/Auto, ddRAura, distributed in Florida, Louisiana, Maryland, Mississippi, New Jersey, New York. The recall was initiated on 5 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1880-2018
- FDA event ID
- 79848
- Recalling firm
- Visaris DOO, Belgrade
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Apr 2018
- FDA classified
- 15 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 5 Apr 2018 | Recall initiated by company | |
| 15 May 2018 | Classified by FDA | +40 days |
| 23 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Visaris Vision/Auto, ddRAura recalled?
Yes. Visaris DOO recalled Visaris Vision/Auto, ddRAura on 5 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-1880-2018.
Why was it 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.
Which lots are affected?
System SN VC16B-02002, Column SN BA-215-1800-862-1-30008; System SN VC15L-02002, Column SN BA-215-1800-862-1-30015; System SN VC15L-01002, Column SN BA-215-1800-862-1-30011; System SN VC15J-01002, Column SN BA-215-1500-792-10001; System SN VC15I-02001, Column SN BA-215-1800-862-1-30006
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Visaris DOO
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Visaris Vision/Auto, ddRAura recalled by Visaris DOO | Visaris DOO | Device Malfunction | 6 states |
| Device | CLASS II | Visaris Vision/Auto, ddRAura recalled by Visaris DOO | Visaris DOO | Device Malfunction | 6 states |
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