FDA Medical Device Recalls (openFDA)
Agfa N.V.: 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
- Recall number
- Z-1502-2020
- Recalling firm
- Agfa N.V.
- Product
- 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
- Status
- Terminated
- Initiated
- 2020-02-10
- Posted
- not on file
- Terminated
- 2023-03-30
- Reason
- Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of FL, VA.
- Lot, serial or model codes
- Serial Numbers: 00949, 1161
- 510(k) numbers
- ["K183275"]
- PMA numbers
- not on file
- Product code
- IZF
- Firm FEI
- 3001556265
- Firm city
- Mortsel
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28