FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for g
Summary
The FDA issued a Class II for FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for by FUJIFILM Healthcare Americas Corporation. Reason: 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 patie.
Details
Source
Device Recall
External ID
Z-1470-2023
Action Date
2023-05-03
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.
Quantity Affected: 77 units
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-27
Company
Lexington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (FUJIFILM Healthcare Americas Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FUJIFILM Healthcare Americas Corporation have FDA actions?
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1470-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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