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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Visaris DOO
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
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:
Distributed in: US, FL, LA, MD, MS, NJ, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1881-2018
Related Recalls
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.
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.