Visaris DOO: 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.

Agency Publication Date: May 15, 2018

Affected Products

Product: 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

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

Product: 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

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;

Product: 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 departments. The system s versatility also makes it suitable for unified diagnostic imaging services for

US Systems: System SN VC17J-02002, Column SN BA-215-1800-862-1-3 0019; System SN VC17F-01002, Column SN BA-215-1800-862-1-3 0035; System SN VC17C-01002, Column SN BA-215-1800-862-1-3 0031; International Systems: System SN VC17J-02002, Column SN BA-215-1800-862-1-3 0034; System SN VC17I-01002, Column SN BA-215-1500-792-1 0016; System SN VC17G-02002, Column SN BA-215-1800-862-1-3 0023; System SN VC16K-01002, Column SN BA-215-1800-862-1-3 0032;

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79848

Status: Resolved

Manufacturer: Visaris DOO

Units Affected: 3 products (8 devices (US), 14 devices (international))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products