Siemens Luminos dRF Fluoroscopic X-Ray System Recalled for Software Error
Siemens is recalling four Luminos dRF Fluoroscopic X-Ray systems due to a software error that may cause the table to tilt and collide with the floor.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential physical damage or injury without confirmed incidents.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling four Siemens Luminos dRF Fluoroscopic X-Ray systems. The recall is due to an unintended behavior associated with software version VD10A, where a software error may cause the table to tilt into an upright position and collide with the floor.
The affected units were distributed in the United States, specifically in California, Indiana, New Jersey, and Oklahoma. The specific model number is 10094200, and the affected serial numbers are 4024, 4077, 4043, and 4051.
Siemens notified all four consignees of this recall via Update Instruction XP067/12/S. According to the source text, all four units have already been corrected.
The recalled product
- Product
- Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 4
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 (4)
- Model number 10094200
- serial numbers 4024
- 4077
- 4043 and 4051
Distribution
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