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

Recall Insight

This FDA Devices action (record #Z-1880-2018) 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 indicate 8 devices (US), 14 devices (international) units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.