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FDAJuly 25, 2025device

ZAP-X Radiosurgery System, Model: 300150

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.

What to do

FDA enforcement status: Ongoing

Brands named

zap surgical systemszapzap surgical

UPCs

00860183001504

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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ZAP-X Radiosurgery System, Model: 300150 — Recall Details · AllClear