Mortsel, Belgium
Agfa N.V. recalls
7 recalls recorded since 2018, most recently on 29 July 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)2
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 July 2024
- Reason
- Potential for the front lever chain of the DR 800 table to fail.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, KS, LA, MA, MO, NJ, NC, OH, OK, SC, VA, WV, WI; and the countries of AU, BE, BW, CA, CO, CZ, DE, ES, FR, GB, GR, IL, IN, IT, KZ, MX, PL, RS, UZ, ZA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2738-2024
- DR 800. Digital Radiography X-ray System.
Ongoing Class II Medical devices
- Recall started
- 23 February 2024
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Argentina, Australia, Austria, Belgium, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Mexico, New Zealand, Norway, Peru, Poland, Romania, Russian Federation, Saudi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1462-2024
- Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray i
Terminated Class II Medical devices
- Recall started
- 6 April 2020
- Terminated
- 3 April 2023
- Reason
- Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
- Distribution
- US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2202-2020
- 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 se
Terminated Class II Medical devices
- Recall started
- 10 February 2020
- Terminated
- 30 March 2023
- Reason
- Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
- Distribution
- US Nationwide distribution in the states of FL, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1502-2020
- 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 inte
Terminated Class II Medical devices
- Recall started
- 27 June 2019
- Terminated
- 3 June 2020
- Reason
- The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-2056-2019
- 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
Terminated Class III Medical devices
- Recall started
- 25 January 2019
- Terminated
- 14 June 2019
- Reason
- 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
- Distribution
- US nationwide distribution in the state of OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1034-2019
- PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility o
Terminated Class II Medical devices
- Recall started
- 15 August 2018
- Terminated
- 23 June 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA, DC, FL, IL, IN, KS, LA, MA, MN, MO, NV, NY, OH, OR, SC and TN. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3245-2018
- 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, proces
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.