FujiFilm FDR AQRO recall
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images…
Why was FujiFilm FDR AQRO 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.
- Product
- FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images…
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 77 units
- Distribution
- US Nationwide distribution.
- Recall date
- May 3, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)