FDA Enforcement
Class II
Ongoing
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
Recall: Z-2185-2024
·
Reported July 3, 2024
Enforcement
- Recall Number
- Z-2185-2024
- Event ID
- 94777
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- July 3, 2024
- Initiation Date
- May 31, 2024
- Classification Date
- June 25, 2024
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418, United States
Description
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
Reason
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Code Info
UDI-DI: N/A Serial Numbers: 1004 1006 1011 1014
Distribution
US Nationwide distribution.
Quantity
4 units