Agency classClass IIOur severity:High FDA (Devices)·Z-1882-2018·Announced 2018-05-23

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

Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and injury.

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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Visaris DOO is recalling 22 units of the Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4. The recall covers 8 devices distributed in the United States and 14 devices distributed internationally. In the US, the affected systems were distributed to Florida, Louisiana, Maryland, Mississippi, New Jersey, and New York. Internationally, the systems were distributed to 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 an uncontrollable descent of the tube arm. This failure presents a potential risk of injury to the patient.

Specific serial numbers for the affected US and international systems are listed in the structured product information. Users of these systems should contact Visaris DOO for further instructions regarding the recall and necessary corrective actions.

The recalled product

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

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 (14)

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

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

Same hazard · mechanical failure