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Zap Surgical Systems, Inc.

Active in EUDAMED
Also registered as Zap Surgical Systems

United Statesfrom SRN EUDAMED SRN US-MF-000001198

Devices
12
Registrations
EUDAMED
FDA recalls
22 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA recalls

What Zap Surgical Systems, Inc. makes

Zap Surgical Systems, Inc. develops and manufactures systems for stereotactic radiosurgery and radiation therapy, including linear accelerator platforms. Their portfolio includes imaging solutions like the Zap-X MV Imager, as well as treatment planning and delivery software (Zap-X Treatment Planning Software, Zap-X Treatment Delivery Software). The company also produces the ZAP-X Radiosurgical System, designed for precise radiosurgical interventions.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These systems are intended for use in the United States, where the manufacturer is based.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

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Company details

EUDAMED SRN
US-MF-000001198
DUNS number
082344400
EU VAT number
NL 826272873B01
EUDAMED status
Active since 2021
EUDAMED registered name
ZAP Surgical Systems, Inc.
Registered address
590, Taylor Way, 94070, San Carlos, California, United States
Phone
+1 877-699-5843
PRRC contact
Junyi Wang(public in EUDAMED)

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Zap Surgical Systems, Inc., the earliest on 2022-07-05 and the most recent on 2025-07-25. By recorded status: 2 ongoing. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 0
  • 2024 0
  • 2025 1
  • 2026 0

  • 2025

    • 25 Jul 2025 Z-2639-2025 Class II Ongoing 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. Distribution: Worldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the countries of Germany, France, Spain,…
      Full distribution text 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.
      Submission number: K211663

  • 2022

    • 5 Jul 2022 Z-1742-2022 Class II Ongoing 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 calculate the new treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter. Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN. Submission number: K211663

Frequently asked questions

How many devices does Zap Surgical Systems, Inc. have in the registry?

The registry currently lists 12 devices for Zap Surgical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Zap Surgical Systems, Inc.'s devices?

Among its 12 most recently registered devices, Zap Surgical Systems, Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (4 devices) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Zap Surgical Systems, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Zap Surgical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Zap Surgical Systems, Inc.?

FDA recall records list 2 recalls initiated by Zap Surgical Systems, Inc., the most recent initiated on 2025-07-25. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Zap Surgical Systems, Inc. in the registry?

The most recently registered devices listed for Zap Surgical Systems, Inc. include PinZ Patient Immobilizer 465830, Kit, Container, Head Immobilizer 300154, ZAP-Axon Treatment Planning System 300157 and DoseGuard 300158.

Generated automatically from registry data and not verified by a human reviewer.