Zap Surgical Systems recall records

2 reported ongoing

2 records in this archive. Latest source date Jul 25, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

ZAP-X Radiosurgery System, Model: 300150

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 collimato...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the countries of Germany, France, Spain, Poland, Republic of Korea, T¿rkiye, Paraguay.

Official source for ZAP-X Radiosurgery System, Model: 300150
FDA device enforcement

ZAP-X Radiosurgery System

Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algori...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.

Official source for ZAP-X Radiosurgery System

Reasons in these listed records

  • 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 pa...
  • Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly ...

These examples come from this result page and are not a ranking of every recall reason.

Checking Zap Surgical Systems

Is there a recall on zap surgical systems right now?

This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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