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OLINDA/EXM

Hermes Medical Solutions AB · Model 00859873006035 · UDI-DI 00859873006035

IYX Prescription

510(k) clearances

404

Adverse events (5 deaths)

Recalls

Facilities

Description

The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.

Recalls

Date	Firm	Reason
2025-12-10	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affecte
2025-12-10	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affecte
2016-08-05	Siemens 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 the patient positionin
2004-07-30	General Electric Med Systems	The 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 drive assembly can back
2004-07-30	General Electric Med Systems	The 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 drive assembly can back
2004-01-16	GVI Technology Partners	Due to limitations in the operating software, the acquired scan may not be processed properly.
2003-02-10	Siemens Medical Solutions USA, Inc.	Unintended yoke rotational motion.

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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.