Fluoroscopic X-ray systems recalled over limited system movements after startup
Artis Pheno image-intensified fluoroscopic X-ray systems are recalled because of limited system movements after startup. 20 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice reports limited system movement after startup without stating any patient consequence.
Plain-English summary
The Artis Pheno image-intensified fluoroscopic X-ray system, model number 10849000, UDI 04056869046877, is being recalled. Affected serial numbers include 164184, 164183, 164071, 164072, 164027, 164026 and 164094, with the full list in the recall notice. The recall covers 20 units distributed across 12 states.
The recall was issued because of limited system movements after startup. The FDA classified the action as Class II. The notice does not describe a further consequence.
Imaging sites operating these systems should follow the manufacturer's instructions for correction.
The recalled product
- Product
- Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging System
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 10849000
- UDI: 04056869046877
- Serial No. 164184
- 164183
- 164071
- 164072
- 164027
- 164026
- 164094
- 164019
- 164161
- 164152
- 164069
- 164086
- 164084
- 164158
- 164188
- 164105
- 164080
- 164011
Distribution
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