Agency classClass IIOur severity:High FDA (Devices)·Z-1880-2018·Announced 2018-05-23

Visaris Diagnostic X-Ray System Recalled for Tube Arm Suspension Failure

Visaris DOO is recalling specific diagnostic X-ray systems due to a potential failure in the tube arm suspension that could cause the arm to descend uncontrollably.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Visaris DOO is recalling specific units of the Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2. The recall involves 8 devices in the United States and 14 devices internationally. The affected systems were distributed in the US states of Florida, Louisiana, Maryland, Mississippi, New Jersey, and New York, as well as in the Czech Republic, Germany, Serbia, Switzerland, Taiwan, and the United Kingdom.

The recall is being conducted because a failure of the tube arm suspension is possible while the tube arm height is being adjusted. There is a small probability that both the primary and redundant holding mechanisms could fail, causing the tube arm to descend uncontrollably. This poses a potential risk of injury to the patient.

Healthcare facilities and users should identify if they possess any of the affected serial numbers listed in the recall notice. Users should contact Visaris DOO for instructions on how to resolve the issue.

The recalled product

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…
Manufacturer: Visaris DOO
Category: Medical Device — Diagnostic Imaging
Hazard: falling-object
mechanical-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

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

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 3 recalled by Visaris DOO under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Visaris DOO

See all →

High
Visaris Diagnostic X-Ray Systems Recalled for Tube Arm Suspension Failure Risk
FDA (Devices) · 2018-05-23
High
Visaris Diagnostic X-Ray System Recalled for Tube Arm Suspension Failure
FDA (Devices) · 2018-05-23

Same hazard · falling object