Siemens Recalls Angiographic X-Ray Systems Due to Table Collision Risk
Siemens is recalling 51 angiographic x-ray systems because a malfunction in the table vertical lift could cause a collision if obstructed by a solid object.
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 is classified as FDA Class II and involves a risk-of-harm product (collision hazard) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 51 units of Iconos and Luminos angiographic x-ray systems. The affected models include the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion, and Luminos Select.
The recall is due to a potential malfunction in the table vertical lift movement. If this movement is obstructed by a solid object, it could potentially result in a collision, posing a hazard to patients and staff. The affected units were distributed nationwide, including in California, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New York, Nevada, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Washington.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 51
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 Number 5902767 with serial numbers 2217
- 2038
- 1228
- 1007
- 1219
- 2156
- 2264
- 2190
- 2132
- 2213
- 1484
- 2166
- 2259
- 2068
- 1610
- 1601
- 1413
- 2236
- 2153
- 1444
Distribution
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