FDA Device recall Z-1882-2018
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnost…
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnost… by Visaris Doo, citing 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 pri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1882-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-05 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Visaris Doo |
| Distribution | FL, LA, MD, MS, NJ, NY |
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 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
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.
Identifiers
| code_info | US Systems: System SN VC17J-02002, Column SN BA-215-1800-862-1-3 0019; System SN VC17F-01002, Column SN BA-215-1800-8…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1882-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.