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Use caution Medical device recall · FDA · Published February 27, 2023

FujiFilm FDR AQRO DR-XD1000 X-ray System Recall: Risk of Serious Injury from Broken Arm

FujiFilm recalls digital mobile X-ray systems (DR-XD1000) due to risk of serious injury from a breakable arm component. Affected units have serial numbers ending 0001-1993. Contact for repair or return.

🇺🇸 FDA recall #Z-1470-2023Medical deviceFUJIFILM Healthcare ›
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Contact the company

Recalling firmFUJIFILM Healthcare Americas Corporation81 Hartwell Ave Ste 300 · Lexington, MA 02421-3160
✎ GovInfoNow plain-language explainer

FujiFilm is recalling its DR-XD1000 digital mobile X-ray systems because the arm holding the X-ray tube can break, potentially causing serious injury to patients or users. This recall affects units sold between 2007 and 2008 with specific serial numbers. Read more at govinfonow.com/recall/58848-fujifilm-fdr-aqro-dr-xd1000-x-ray-system-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58848-fujifilm-fdr-aqro-dr-xd1000-x-ray-system-recall-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1470-2023

Cite this page

“FujiFilm FDR AQRO DR-XD1000 X-ray System Recall: Risk of Serious Injury from Broken Arm.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58848-fujifilm-fdr-aqro-dr-xd1000-x-ray-system-recall-risk. Based on FDA recall #Z-1470-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1470-2023%22&limit=1).

The FDA announced on Feb. 27, 2023, that FUJIFILM Healthcare Americas Corporation is recalling FujiFilm FDR AQRO digital mobile X-ray systems because the arm holding the tube head may break, potentially causing serious harm or injury to patients and users.

How to tell if you have it

  • Brand: FUJIFILM Healthcare
  • Product: FujiFilm FDR AQRO (Model DR-XD1000)
  • UPC: 04547410425505
  • Serial numbers ending in ****0001 to ****1993

The hazard

According to the FDA, the 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.

Context

GovInfoNow's records show FUJIFILM Healthcare Americas Corporation has had 13 other recalls on record since Oct. 14, 2021. Other recent recalls of similar products include Canon Alphenix X-ray Systems Recall (Aug. 4, 2026), Canon Alphenix INFX-8000F X-Ray System Recall (Dec. 19, 2025), and GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026).

How to tell if you have this one

Check the serial number on your DR-XD1000 X-ray system. Units with last 4 digits from 0001 to 1993 were sold between 2007 and 2008.

  • Brand
    FUJIFILM Healthcare
  • Product
    FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Look for the serial number on the device; affected units end with last 4 digits between 0001 and 1993.

  2. Contact FujiFilm

    Reach out to FujiFilm Healthcare Americas for repair or return instructions.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Feb 27, 202312. FDA classified it Class II: Apr 27, 202323. Published in FDA’s Enforcement Report: May 3, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1470-2023 (February 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1470-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA