Siemens Medical Solutions USA, Inc Recall: Siemens AXIOM Luminos dRF Max systems The Axiom
Siemens Medical Solutions USA, Inc Recall: Siemens AXIOM Luminos dRF Max systems The Axiom is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Siemens Medical Solutions USA, Inc; Product: Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diag
| Recalling firm | Siemens Medical Solutions USA, Inc |
|---|---|
| Product | 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. |
| Reason for recall | 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY. |
| Recall initiated | 20140902 |
| Recall number | Z-0003-2015 |
| Category | device |
| State | PA |
| Country | United States |
$29/mo
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