Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Reported: March 1, 2023 Initiated: December 21, 2022 #Z-1165-2023
Product Description
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 28 units. Expanded Recall: 506 units
- Distribution
- US Nationwide distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 28 units. Expanded Recall: 506 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 1, 2023. Severity: Moderate. Recall number: Z-1165-2023.
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