Facility

ZAP SURGICAL SYSTEMS INC.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012039133
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	590 Taylor Way San Carlos, CA, US 94070
Registration status	Active · expires 2026
Parent company	Zap Surgical Systems Inc. (owner-operator 10058325)
Brand names	ZAP-X Radiosurgery System

Activity by year

Recalls (2)

Devices registered here (1)

Accelerator, Linear, Medical
Product code IYE (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050

Recalls & enforcement

Class IIOngoing2025-07-25
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 patie…
Class IIOngoing2022-07-05
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 cal…

All facilities operated by Zap Surgical Systems Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ZAP SURGICAL SYSTEMS INC. (FEI 3012039133) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012039133-zap-surgical-systems-inc/

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