Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number
Summary
The FDA issued a Class II for Luminos Agile with software VC10 - A diagnostic imaging system for radiographic 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-1164-2023
Action Date
2023-03-01
Status
Ongoing
Category
device
Product Description
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Lot/Code Info: UDI: N/A S/N: 60040 60018 60223 60015 Expanded Recall 2/24/23: S/N: 60011 60037 60041 60043 60051 60055 60056 60062 60067 60071 60072 60075 60076 60081 60087 60089 60092 60093 60095 60103 60111 60114 60118 60133 60138 60140 60141 60143 60146 60155 60162 60171 60172 60173 60178 60183 60184 60186 60187 60188 60192 60194 60196 60204 60208 60214 60219 60220 60221 60225 60227 60228 60230 60231 60234 60238 60239 60255 60259 60262 60264 60267 60273 60274 60277 60279 60286 60404 60408 60409 60412 60413 60414 60416 60417 60423 60424 60425 60429 60433 60436 60440 60441 60445 60446 60450 60452 60459 60464 60465 60466 60469 60473
Quantity Affected: 4 units. Expanded Recall: 93 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-1164-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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