CLASS II ONGOING Device recall · Reported 3 May 2023 · FDA Enforcement Report
FujiFilm FDR AQRO recalled by FUJIFILM Healthcare Americas
FUJIFILM Healthcare Americas is recalling FujiFilm FDR AQRO (, distributed nationwide in the US. The recall was initiated on 27 Feb 2023 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-1470-2023
- FDA event ID
- 92012
- Recalling firm
- FUJIFILM Healthcare Americas, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2023
- FDA classified
- 27 Apr 2023
- Reported
- 3 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 27 Feb 2023 | Recall initiated by company | |
| 27 Apr 2023 | Classified by FDA | +59 days |
| 3 May 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.
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
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is FujiFilm FDR AQRO ( recalled?
Yes. FUJIFILM Healthcare Americas recalled FujiFilm FDR AQRO ( on 27 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1470-2023.
Why was it recalled?
Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.
Which lots are affected?
UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.
Where was it sold?
US Nationwide distribution.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from FUJIFILM Healthcare Americas
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