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Volcano s5/s5i/CORE Intravascular Ultrasound Systems with… recallZ-2131-2015 · Volcano Corporation · initiated Jun 22, 2015

Class II Terminated All recalls posted in July 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Volcano Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

FDA root cause category: Software design

What the company is doing

Urgent Medical Device Correction letters were sent on June 22, 2015 to all affected sites via FED Ex.

Recall details

Recall number
Z-2131-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 22, 2015
Posted by the FDA
Jul 20, 2015
Recalling firm
Volcano Corporation
Quantity
Total of 4007 devices, all models
Product code
IYO
FDA submissions
K123898
Distribution
Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina

Product description

Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

Code information (models, lots, serial numbers)

Model s5. Part numbers: 804200-002 and 804200-014

Other devices under the same FDA submission

2 devices cleared under K123898 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 71654).

Sources and updates

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