Z-0923-2026 Class II Ongoing
FDA device recall Z-0923-2026 was initiated by AGFA Healthcare Corp. on Nov 18, 2025 and is designated Class II. Reason for recall: It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not… The recall status is ongoing. Affected quantity: 35.
Recall details
- Product Type
- Devices
- Report Date
- Dec 31, 2025
- Initiation Date
- Nov 18, 2025
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 35
Product description
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Reason for recall
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Distribution pattern
U.S. Nationwide distribution.
Code information
N/A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0923-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026