Visaris Vision/Auto recall
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…
Why was Visaris Vision/Auto recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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 2.2 The Vision systems are intended for use in all areas of diagnostic…
- Recalling firm
- Visaris DOO
- Quantity
- 8 devices (US), 14 devices (international)
- Distribution
- Worldwide Distribution - US Distribution to the states of : FL, LA, MD, MS, NJ, and NY., and to the countries of : Czech Republic, Germany, Serbia, Switzerland, Taiwan, and United Kingdom.
- Recall date
- May 23, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)