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FDA-Device2014-10-08Class IIPROCESSING DEFECT

Siemens AXIOM Luminos dRF Max X-ray system recalled for lost images and labeling errors

Siemens
OTHERNationwide distribution

Check your Siemens AXIOM Luminos dRF Max system

Siemens identified a software malfunction in certain AXIOM Luminos dRF Max X-ray imaging systems that can cause medical images to be lost during automatic updates. When this happens, patients may need to repeat their imaging exams. Image labels may also display incorrectly on affected systems.

  • If you operate a Siemens AXIOM Luminos dRF Max system, check your device's serial number against Siemens' list of affected units
  • Contact Siemens Medical Solutions immediately if your system is affected
  • Do not perform exams until your system has been evaluated or updated by Siemens
Hazard

Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images

Sold states
Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.
Affected count
1
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0003-2015

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