Agfa recalls DR 800 X-Ray systems with model numbers 00925, 00945, 00949, 1136 due to possible fluoroscopy area mismatch with detector, risking inaccurate imaging.
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Agfa is recalling its DR 800 digital radiography X-ray systems that may have mismatched fluoroscopy areas with the detector. This could lead to inaccurate imaging during medical procedures, potentially affecting diagnosis and treatment.
The fluoroscopy imaging area might not align properly with the detector's active area within specified limits. This mismatch could cause the system to produce images that don't accurately represent the body part being examined, potentially leading to incorrect medical decisions.
Healthcare facilities using the Agfa DR 800 system with model numbers 00925, 00945, 00949, or 1136 are likely affected. Medical staff and patients using these systems for fluoroscopy procedures are at risk of inaccurate imaging results.
Check for model numbers 00925, 00945, 00949, or 1136 on the DR 800 system. The system is intended for dynamic imaging like fluoroscopy and rapid sequence procedures, not mammography.
Identify if your DR 800 system has model numbers 00925, 00945, 00949, or 1136.
The fluoroscopy imaging area may not match the detector's active area within specified limits, potentially causing inaccurate imaging during medical procedures.
Model numbers 00925, 00945, 00949, and 1136.
The recall record does not specify a remedy.
We’ve drafted a message you can send Agfa to request your refund or repair — edit it as you like.
Subject: Recall Z-2056-2019 — Agfa Agfa Hello, I own a Agfa that is covered by recall Z-2056-2019 from Agfa. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
