CLASS II ONGOING Device recall · Reported 1 Feb 2023 · FDA Enforcement Report
Enterprise Imaging XERO Viewer recalled by Agfa Healthcare NV
Agfa Healthcare is recalling Enterprise Imaging XERO Viewer. The recall was initiated on 5 Dec 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1004-2023
- FDA event ID
- 91357
- Recalling firm
- Agfa Healthcare, Mortsel, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Dec 2022
- FDA classified
- 20 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 5 Dec 2022 | Recall initiated by company | |
| 20 Jan 2023 | Classified by FDA | +46 days |
| 1 Feb 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a software defect that can cause issues with images.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Agfa HealthCare Enterprise Imaging XERO Viewer
Where it was distributed
Distribution throughout US OUS distribution to Australia, Belgium, Brazil, Canada, Chile, Cyprus, France, Iceland, Ireland, Italy, Kenya, Luxembourg, Netherlands, Romania, Saudi Arabia, Spain, Sweden, United Kingdom, South Africa
Questions about this recall
Why was it recalled?
There is a software defect that can cause issues with images.
Which lots are affected?
Affected software versions include: XERO Viewer 8.1.4.100 or higher XERO Viewer 8.2.0.000 or higher XERO Viewer 8.2.1.000 or higher UDI/DI: 05400874000710
Where was it sold?
Distribution throughout US OUS distribution to Australia, Belgium, Brazil, Canada, Chile, Cyprus, France, Iceland, Ireland, Italy, Kenya, Luxembourg, Netherlands, Romania, Saudi Arabia, Spain, Sweden, United Kingdom, South Africa
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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