Visaris DOO: Medical Device Recall in 2018 - (Recall #: Z-1881-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 5, 2018

Date Posted: May 23, 2018

Recall Number: Z-1881-2018

Event ID: 79848

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.

Status: Terminated

Product Quantity: 8 devices (US), 14 devices (international)

Code Information:

US Systems: System SN VC16J-01002, Column SN BA-215-1800-862-1-3 0022; System SN VC16F-04002, Column SN BA-215-1800-862-1-3 0026; System SN VC16E-02002, Column SN BA-215-1500-792-1 0004; System SN VC16E-01002, Column SN BA-215-1500-792-1 0003; System SN VC15K-01002, Column SN BA-215-1500-792-1 0002; International Systems: System SN VC16H-01002, Column SN BA-215-1500-792-1 0007; System SN VC16F-03002, Column SN BA-215-1800-862-1-3 0007; System SN VC16F-01002, Column SN BA-215-1500-792-1 0004; System SN VC16F-02002, Column SN BA-215-1800-862-1-3 0012;

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated