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PeekMed
PEEK HEALTH, S.A. · Model v2 · UDI-DI 05600120304801
1
510(k) clearances
19,970
Adverse events (41 deaths)
561
Recalls
635
Facilities
Description
PeekMed is a system that allows healthcare professionals to plan a surgery procedure simulating various environments, from hybrid (2D/3D) to 3D or 2D environments. In the case of a 3D or hybrid 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, i.e. screws, fixation plates, or full prosthesis, deriving from several producing companies. Being software it does not interact with any part of the body of the user and/or patient.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 2026-06-30 | Merge Healthcare, Inc. | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. |
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Get your free API keyRead the docsData 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.