FDA (Devices) recall action 91518
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens is recalling the Biograph Horizon 3R Mobile PET/CT system due to a potential failure of the locking mechanism that secures the PET gantry in its scanning or service position. The system has been distributed worldwide.
The SIEMENS Biograph mCT PET scanner has a potential issue with the locking mechanism that secures the gantry. Six units distributed worldwide including the US, Japan, Chile, and Australia are affected.
Siemens recalls Biograph Vision PET scanners worldwide for a potential defect in the gantry locking mechanism that secures the equipment during scanning and service.