FDA Device Intelligence
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Camera, Scintillation (Gamma)

FDA product code IYX · Class 1 · Radiology

127
Registered devices
404
Adverse events
7
Recalls
130
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-12-10GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and l
2025-12-10GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and l
2016-08-05Siemens Medical Solutions USA, Inc."We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of th
2004-07-30General Electric Med SystemsThe detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial dri
2004-07-30General Electric Med SystemsThe detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial dri
2004-01-16GVI Technology PartnersDue to limitations in the operating software, the acquired scan may not be processed properly.
2003-02-10Siemens Medical Solutions USA, Inc.Unintended yoke rotational motion.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.