Recall – Digital angiography system application terminates after certain steps

Company: Shimadzu Medical Systems Usa Com
Date of Enforcement Report: 3/6/2019
Class II:

PRODUCT

DIGITAL ANGIOGRAPHY SYSTEM: This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.

Recall Number: Z-0959-2019

REASON

Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.

RECALLING FIRM/MANUFACTURER

Shimadzu Medical Systems Usa Com on 1/14/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8 units

DISTRIBUTION

US Nationwide

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Partners located in the US (CA, FL, MA, MN) and Italy.