Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie M
Summary
The FDA issued a Class II for Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for by Siemens Medical Solutions USA, Inc. Reason: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration param.
Details
Source
Device Recall
External ID
Z-1167-2023
Action Date
2023-03-01
Status
Ongoing
Category
device
Product Description
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Lot/Code Info: UDI: 4056869009162 S/N: 5037 5951 Expanded Recall 2/24/23: 5069 5085 5209 5234 5340 5364 5634 5664 5682 5919 5920 5921 5947 5953 5954 5956 5963 7075 7098 7147 7162 7168 7172 7208 7266 7310 7319 7391 7404 7442 7460 7488 7545 7743 7771 8074 8093 8094 8183 8198 8223 8242 8244 8275 8320 8322 8334 8361 8371 8378 8385 8389
Quantity Affected: 2 units; Expanded recall: 53 units
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
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-21
Company
Malvern, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 136 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1167-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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