FDA (Devices) recall action 88588
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.
Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).
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 radiation therapy planning software may lose data when editing treatment structures. Incomplete structure sets could be sent to the treatment planning system, affecting treatment plan accuracy.
Siemens syngo.CT software used in radiation therapy systems may lose treatment structure data during edit and reopen operations, sending incomplete treatment information to planning systems.
Siemens MR MAGNETOM imaging systems may lose treatment planning data when editing structure sets after reopening a saved study, resulting in incomplete treatment plans being transmitted to planning systems.