Z-1166-2023 Class II Ongoing
FDA device recall Z-1166-2023 was initiated by Siemens Medical Solutions USA, Inc on Dec 21, 2022 and is designated Class II. Reason for recall: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values The recall status is ongoing. Affected quantity: 1 unit; Expanded Recall: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 1, 2023
- Initiation Date
- Dec 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit; Expanded Recall: 25 units
Product Description
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
Reason for Recall
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: N/A S/N: 4650 Expanded Recall 2/24/23: 4043 4051 4143 4156 4199 4201 4238 4252 4291 4323 4332 4342 4354 4372 4401 4430 4508 4600 4606 4637 4641 4683 4722 4724 4734
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1166-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026