IntraSight Mobile IVUS touch screen modules missing required labeling information
IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall involving missing labeling information with no reported illnesses or injuries. The hazard is documentation-related rather than a functional device defect, consistent with Class III recalls which are typically scored 1-2.
Plain-English summary
Volcano Corp is recalling 47 Multi-Modality Touch Screen Modules (MM-TSM) used as bedside control units in IntraSight Mobile IVUS Systems, Model 797415, Part numbers 300002018101 and 300002018102. The affected modules are missing required labeling information.
The touch screen modules are missing the Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information required for proper device identification and clinical use.
The affected units were distributed to healthcare facilities in California, Colorado, Georgia, Massachusetts, Texas, Arizona, New York, Pennsylvania, Florida, Missouri, Oregon, Maryland, North Carolina, and Tennessee. International distribution included facilities in Japan, Germany, United Kingdom, Netherlands, and Italy.
Healthcare providers using IntraSight Mobile IVUS Systems should verify that their touch screen modules display all required labeling information. Those with affected units should contact Volcano Corp for corrective labeling or replacement.
The recalled product
- Product
- IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
- Manufacturer
- Volcano Corp
- Hazard
- Affected units
- 47
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 (2)
- All MM-TSM units
- Device Identifier (DI): 00845225012915
Distribution
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