Volcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
Volcano Corp is recalling 19 Philips IntraSight Plus systems because software may incorrectly associate patient image data with the wrong medical record.
What this means for you
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall, and the source text explicitly states the defect could result in incorrect diagnosis or treatment, which aligns with the rubric criteria for significant injury or risk of harm.
Plain-English summary
Volcano Corp is recalling 19 units of the Philips IntraSight Plus system (REF: 797423 and 797417) equipped with Software Version 6.0.4. The recall was initiated by the U.S. Food and Drug Administration (FDA) and classified as Class II.
The recall is due to a software defect that may cause the system to associate image data from one patient with another patient's record. This error could potentially result in an incorrect diagnosis or treatment for the affected patients.
The affected systems were distributed worldwide, including in the United States (MA, MN, TX, AL, GA, CA) and in Belgium, Denmark, Germany, Netherlands, Poland, Spain, Sweden, and the United Kingdom. Healthcare facilities should contact Volcano Corp for instructions on how to resolve the issue.
The recalled product
- Product
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
- Manufacturer
- Volcano Corp
- Affected units
- 19
Distribution
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