Siemens MAGNETOM headphones may create artifacts during MRI imaging
Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.
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: FDA Class II medical device recall with no reported patient illnesses or injuries. The hazard is conditional image artifact generation that may affect diagnostic image quality, fitting the profile of a moderate-level precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling over-ear headphones (Model 11060845, serial numbers 7981 to 32200) used with MAGNETOM MRI imaging systems. In some cases, lubricating grease within the headphone headband may produce visible, dot- or line-shaped artifacts in MRI head examination images. These artifacts depend on the position of the headband, the amount of grease, and the MRI sequence parameters used.
No patient injuries or illnesses have been reported. The recall affects 3,470 units in the United States and 13,265 units worldwide that are used with various MAGNETOM MRI system models.
Healthcare providers should be aware of this potential artifact source when using or reviewing images from these headphones.
The recalled product
- Product
- (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — MRI accessories
- Hazard
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 (7)
- (1)Model/Material Number/UDI: MAGNETOM FREE.MAX 11408425 UDI: 04056869281742
- MAGNETOM AMIRA 10836777 UDI: 04056869006819
- MAGENTOM AMIRA 10838610 UDI: 04056869020488
- MAGNETOM FREE.Max 11408424 UDI: 04056869281759
- MAGNETOM Free.Star 11408426 UDI: 04056869281766
- MAGNETOM Free.Star 11408427 UDI: 0405686981773
- MAGNETOM Mica 11292557 NA
Distribution
Distributed nationwide across the United States.
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