Recall Z-1502-2020 ยท IZF System, X-Ray, Tomographic
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
| Date | Feb 10, 2020 |
| Status | Terminated |
| 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 re |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the states of FL, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183275 | DR 800 with Tomosynthesis Agfa N.V., Feb 1, 2019 |