Class IIOngoingZ-2341-2025
GE Medical Systems, LLC recalls GE HealthCare OEC 9800.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems.…
GE Medical Systems, LL…WISep 3, 2025
Recalls: Radiation Control for Health and Safety Act
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 45 recalls
Class IIOngoingZ-2150-2025
Apic Yamada America recalls Molding Equipment. WCM series. Model WCM-330GL-i
Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.
Apic Yamada AmericaAZAug 6, 2025
Class IIOngoingZ-2149-2025
Jinan Bodor Cnc Machine Co Ltd recalls Bodor's I series laser cutting machine.
The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).
Jinan Bodor Cnc Machin…Jul 30, 2025
Class IIOngoingZ-2117-2025
DIGIMED CO., LTD recalls Portable X-ray system
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
DIGIMED CO., LTDJul 30, 2025
Class IIOngoingZ-2113-2025
Beyond Laser Systems, LLC recalls Laser light show projectors manufactured by BLS
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired.…
Beyond Laser Systems,…TXJul 23, 2025
Class IIOngoingZ-2112-2025
Beyond Laser Systems, LLC recalls Laser light show projectors manufactured by BLS
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired.…
Beyond Laser Systems,…TXJul 23, 2025
Class IIOngoingZ-2111-2025
Beyond Laser Systems, LLC recalls Laser light show projectors manufactured by BLS
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired.…
Beyond Laser Systems,…TXJul 23, 2025
Class IIOngoingZ-2022-2025
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
Siemens Medical Soluti…PAJul 9, 2025
Class IIOngoingZ-2021-2025
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
Siemens Medical Soluti…PAJul 9, 2025
Class IIOngoingZ-2020-2025
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
Siemens Medical Soluti…PAJul 9, 2025
Class IIOngoingZ-2019-2025
Siemens Medical Solutions USA, Inc recalls ARTIS is a family of dedicated angiography systems developed for single and biplane di…
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails.…
Siemens Medical Soluti…PAJul 9, 2025
Class IIOngoingZ-1942-2025
Spectral Instruments Inc recalls Ami HTX.
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
Spectral Instruments I…AZJun 25, 2025