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PeekMed web

PEEK HEALTH, S.A. · Model v1 · UDI-DI 05600120304818

LLZ QIH

510(k) clearances

19,970

Adverse events (41 deaths)

562

Recalls

638

Facilities

Description

PeekMed web is a system that allows healthcare professionals to plan a surgery procedure simulating 2D and 3D environments. In the case of a 3D environment, the healthcare professional can resort to a 3D model generated from a previous imaging study on the patient and 3D digital representations of the implant material to be used during surgery, e.g. screws, fixation plates, or full prosthesis, deriving from several producing companies. The software imports diagnostic imaging studies (e.g. X-rays or Computed Tomography (CT)) from a storage (e.g., CD Rom, local folder). In parallel, there is a database containing digital representations of prosthetic materials (templates) supplied by their respective manufacturers, which offers the possibility of inserting templates during the surgery planning. As PeekMed web is capable of representing the medical images in a 2D and/or 3D environment, performing relevant measurements on those images and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.

Recalls

Date	Firm	Reason
2026-09-10	INTELERAD MEDICAL SYSTEMS INCORPORATED	A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or
2026-09-05	INTELERAD MEDICAL SYSTEMS INCORPORATED	Following a Chromium-based web-browser, report and displayed images may not match.
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-22	Merge Healthcare, Inc.	Software issue may cause measurements to be displayed inaccurately.
2026-07-22	FUJIFILM Healthcare Americas Corporation	Software issue may cause the ruler measurement to be inaccurate.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.