FDA (Devices) recall action 97135
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
The agency’s own wording, quoted from the enforcement report.
Siemens interventional fluoroscopic x-ray systems may fail to communicate dose information between sensor and software, causing incorrect high-dose reporting. The manufacturer is recalling affected units worldwide.
An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
ARTIS angiography systems are being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.