Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 23, 2018
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 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 me
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 pr…
Visaris Doo recalled Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision sy… — a moderate-severity action.
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision sy… was recalled by Visaris Doo in May 23, 2018. Reason: A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube he…. Check the official notice for the remedy. Verify recall #Z-1881-2018 with the FDA Devices before acting.
The recall
Visaris Doo issued this moderate-severity FDA Devices recall — A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube he….
- Moderate
- severity level
- 8 units
- affected scope
- Class II
- classification
- May 23, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1881-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1881-2018) was formally reported on May 23, 2018, with the manufacturer initiating the action on April 5, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Visaris Doo is listed as the recalling firm, operating out of Belgrade. Federal records list the affected scope as 8 devices (US), 14 devices (international).
The documented reason for this recall is: 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, … Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
8 devices (US), 14 devices (international)
Related Recalls
6
6 from same agency
Product description
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1881-2018 |
| Date reported | May 23, 2018 |
| Date initiated | April 5, 2018 |
| Recalling firm | Visaris Doo |
| Firm location | Belgrade |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1881-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 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. Recalled by Visaris Doo. Units affected: 8 devices (US), 14 devices (international).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on May 23, 2018. Severity: Moderate. Recall number: Z-1881-2018.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1881-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 23, 2018.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.