Agfa N.V. Septestraat 27 Mortsel Belgium Recalls

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system

Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible

Agfa issued Urgent Field Safety Notice via email on 4/21/20 to consignees, letter states reason for recall, health risk and action to take: Acknowledgment, via a feedback form or email, that the information was received and understood was requested from the consignees.

AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.

AFGA issued via email On February 10, 2020, an URGENT FIELD SAFETY NOTICE letter. Letter states reason for recall, health risk, and action to take: With this letter, Agfa is informing you that the DR 800 system still can be used including for Tomosynthesis for mAs values which are larger than 0,2 mAs. In case Tomosynthesis image acquisition sequence does not stop automatically after the expected number of exposures, release the exposure button as this will stop the sequence and notify your Agfa Service contact at once. Contact your local Agfa Imaging organization 1-877-777-2432 and please reference Problem Record PRB2000387 and Vigilance Record VR0000716. Complete/Return by fax or email the URGENT FIELD SAFETY NOTICE Feedback form

DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

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.

On August 15, 2018, an "URGENT FIELD SAFETY NOTICE" letter was emailed to the US and Canadian consignees. The letter described the product issue: Breakage of the steel cables that support the equipment to its roof anchor may cause the equipment to fall down and potentially harm the patient, user, or third parties. Actions undertaken by Agfa NV: Soon Agfa NV or its representative will visit your site to do a verification/inspection of your unit related to this topic. Despite the fact that this issue potentially affects older systems with high workload, Agfa NV or its representative will verify/inspect all DX-D 600 systems. Recommended actions to be taken by the customer: If you notice an abnormal displacement in the vertical axis or any suspicious noise during the vertical movement, please notify your Agfa NV Service contact at once. Customers were asked to complete the attached feedback form to confirm receipt.

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project r

The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.