Recall Z-1882-2018 · KPR System, X-Ray, Stationary
Visaris DOO
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 departm
| Date | Apr 5, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Notification letters instruct users to perform the following actions: System end users should: Sign and return the Acknowledgement Form (part of this document). allow Visaris authorized service engineers access to perform the scheduled upgrade and refresher user training Read and familiarize themselves with the current user manual for Vision C devices and safety guidelines provided therein. Within the next four weeks Visaris will prepare and deliver an improved version of the elevation column mechanism for the Vision C devices to all relevant authorized distributors and service organiza |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160620 | Visaris Vision® (Vision C, Vision U. Vision V, Vision X) Visaris D.O.O. Belgrade, Mar 30, 2016 |