Carestream Health recalls OnSight 3D Extremity X-Ray Systems with specific catalog numbers due to potential patient data transfer errors during re-assignment of parent/companion pairs.
When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
Carestream Health is recalling certain OnSight 3D Extremity X-Ray Systems because they may transfer patient data incorrectly when reassigning parent and companion pairs. This could lead to the wrong patient being associated with medical imaging results.
When a user reassigns a parent/companion pair in the system, the parent volume (patient data) transfers to a new patient, but the companion volume remains with the original patient's exam. This could cause incorrect patient data to be linked with imaging results.
Medical professionals using the OnSight 3D Extremity System for x-ray imaging of extremities in adult and pediatric patients aged 12 and over. The risk is low as the issue involves data transfer errors rather than physical harm.
Check for catalog numbers 1743566 (with attached console) or 1743574 (with remote console). The device is used for x-ray imaging of extremities in adult and pediatric patients aged 12 and over.
Identify if your device has catalog numbers 1743566 (with attached console) or 1743574 (with remote console).
The device may transfer patient data incorrectly when reassigning parent and companion pairs, causing the companion volume to stay with the original patient's exam.
The recall record does not mention a remedy or fix.
Check for catalog numbers 1743566 (with attached console) or 1743574 (with remote console).
We’ve drafted a message you can send Carestream Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1207-2019 — Carestream Health Carestream Health Hello, I own a Carestream Health that is covered by recall Z-1207-2019 from Carestream Health. 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.
