Siemens ARTIS Pheno Fluoroscopic X-Ray System Recalled for C-Arm Drop Risk
Siemens is recalling 40 ARTIS Pheno Fluoroscopic X-Ray systems because the C-arm can drop up to 40 mm during specific high-speed rotations.
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 the hazard involves a mechanical drop of the C-arm which poses a risk of harm, but no injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 40 ARTIS Pheno Fluoroscopic X-Ray systems, Model Number 10849000, in the United States. The recall involves a potential safety issue where the C-arm component of the system may drop up to 40 mm (1.6 inches) during specific operational conditions.
The hazard occurs during manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed. In these scenarios, the safety monitoring within the system control may become activated, causing the C-arm to stop rotation and drop. The devices were distributed to facilities in Alabama, California, Colorado, Florida, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, Maine, New Jersey, New York, Ohio, Tennessee, Texas, Utah, and Virginia.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue. The source text does not specify a remediation method, such as a software update or hardware repair, but the recall is active for the identified units.
The recalled product
- Product
- ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 40
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)
- 164033
- 164071
- 164034
- 164095
- 164057
- 164054
- 164055
- 164080
- 164072
- 164088
- 164048
- 164094
- 164068
- 164019
- 164013
- 164073
- 164025
- 164026
- 164027
- 164060
Distribution
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