Agfa N.V Recalls
7 recalls on record · October 3, 2018 to September 4, 2024 · Medical Devices
Recalls by year
18
19
20
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 4, 2024Medical DevicesFDA
Agfa N.V. recalls DR 800. Digital Radiography X-ray System.
Hazard: Potential for the front lever chain of the DR 800 table to fail.
April 10, 2024Medical DevicesFDA
Agfa N.V. recalls Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, gene
Hazard: Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
June 10, 2020Medical DevicesFDA
Agfa N.V. recalls AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s
Hazard: Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
March 25, 2020Medical DevicesFDA
Agfa N.V. recalls AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthe
Hazard: Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
August 7, 2019Medical DevicesFDA
Agfa N.V. recalls AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicat
Hazard: The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
March 27, 2019Medical DevicesFDA
Agfa N.V. recalls PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due
Hazard: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities
October 3, 2018Medical DevicesFDA
Agfa N.V. recalls DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in ho
Hazard: A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.