The Recall Desk
ModerateFDA (Devices)·Z-2345-2012·Announced 2012-09-19

Volcano Intravascular Ultrasound Software Recall Due to Display Changes

Volcano Corporation is recalling specific Intravascular Ultrasound software versions because the system display may change unexpectedly. The issue requires a unique sequence of events to occur.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential display change that requires a unique sequence of events to occur, with no reported injuries or illnesses mentioned in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Volcano Corporation is recalling Volcano brand Intravascular Ultrasound software, specifically the s5/s5i Family Software Version 3.2.1 or 3.2.2. The affected models and part numbers are 435-0607.01, 435-0607.04, 435-0602.01, and 435-0602.02. A total of 1,020 units were distributed worldwide.

The recall is being issued because the display on the system has the potential to change. According to the source text, in-house testing identified that a unique sequence of events must occur for this issue to manifest itself. The product is a medical device used for imaging of histology.

Healthcare facilities and users should contact Volcano Corporation for further instructions on how to address the software issue. No specific consumer actions or dates are provided in the source text beyond the identification of the affected software versions.

The recalled product

Product
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in
Manufacturer
Volcano Corporation
Category
Medical Device — Imaging Software
Hazard
Affected units
1,020

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 (4)

  • All units of these models. Models/Part Numbers: 435-0607.01
  • 435-0607.04
  • 435-0602.01
  • 435-0602.02

Distribution

Distribution scope not specified by the agency.

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