Volcano Corp: IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

Is my product affected?

IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

• UPC 00845225012915

Check against the official notice below — it lists the full affected range.

What happened

Volcano Corp is recalling 47 Multi-Modality Touch Screen Modules (MM-TSM) used as bedside control units for Mobile IVUS Systems, Model 797415. These devices are missing required labeling information including the Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information. The affected units have been distributed in the United States (Colorado, Georgia, Massachusetts, Texas, Arizona, New York, Pennsylvania, California, Florida, Missouri, Oregon, Maryland, North Carolina, and Tennessee) and internationally (Japan, Germany, United Kingdom, Netherlands, and Italy).

The recall affects all MM-TSM units with Device Identifier 00845225012915. The recall record does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.

Details from the source

Reason for recall: Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information. Distribution: US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT Quantity: 47 Lot/code info: All MM-TSM units, Device Identifier (DI): 00845225012915

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Philips Respironics V60 Ventilator Part Number 10536172022-01-24
• Philips Respironics V60 Plus Ventilator Part Number 11387472022-01-24
• LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenish2022-01-27
• LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishment2022-01-27
• LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. La2022-01-27

All FDA (Device enforcement) recalls