Intraoperative ultrasound systems recalled over soldering that can shut them down

Plain-English summary

The Medistim MiraQ System, an ultrasound device for intraoperative use, is being recalled across models MQC04001, MQC14001, MQU14011 and MQV12011.

The Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and the system to shut down. The firm states affected devices need to have their Printer Support Modules replaced.

The recall covers 14 units, identified by serial number, distributed in Colorado, Michigan, Minnesota, Tennessee and Texas, and internationally including Australia, Austria, Germany and Finland. The FDA has classified the action as Class II.

The enforcement record describes the fault and reports no injuries. Because the device is used during surgery, sites operating an affected system should follow Medistim's instructions.

The recalled product

Product

Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No

Manufacturer

Medistim Asa

Category

Medical Device — Ultrasound system

Hazard

• soldering-defect
• unexpected-shutdown
• intraoperative

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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