Medical imaging system recalled for power supply fire risk
Siemens is recalling 2 AXIOM Vertix MD imaging systems nationwide due to a potential fire hazard from a short circuit in the power supply unit that may cause overheating.
What this means for you
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: FDA Class II recall for a risk-of-harm medical device with no reported injuries or illnesses. The potential for fire and overheating poses significant risk in a clinical environment, though the hazard remains theoretical at this time.
Plain-English summary
Siemens Medical Solutions USA, Inc is recalling AXIOM Vertix MD Trauma imaging systems, which are used for emergency and accident patient examination in emergency departments and outpatient clinics. Two units with serial numbers 1040 and 1020 are affected by this recall.
The power supply unit of the Touch Display may experience a short circuit that could lead to overheating and fire. These conditions pose a potential risk to patients and clinical staff.
The affected units have been distributed nationwide. Customers who have these systems should contact Siemens Medical Solutions USA, Inc for information regarding repair, replacement, or other resolution options.
The recalled product
- Product
- AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- fire
- electrical-short-circuit
- overheating
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 (1)
- UDI-DI: N/A Serial Numbers: 1040 1020
Distribution
Distributed nationwide across the United States.
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