LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Mode
Summary
The FDA issued a Class II for LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an by Siemens Medical Solutions USA, Inc. Reason: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the.
Details
Source
Device Recall
External ID
Z-2527-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Lot/Code Info: UDI: (01)04056869269931(21) Serial Numbers: Serial Number 10251 10181 10278 10274 10115 10309 10024 10140 10073 10327 10091 10307 10253 10117 10311 10030 10194 10029 10063 10076 10173 10172 10170 10079 10234 10330
Quantity Affected: 26 units
Reason for Recall
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-02
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 158 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-2527-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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