Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Luminos Agile

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Luminos Agile see related information
Date Initiated by Firm December 21, 2022
Date Posted February 23, 2023
Recall Status1 Open3, Classified
Recall Number Z-1164-2023
Recall Event ID 91649
510(K)Number K062623  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Luminos Agile with software VC10 - A diagnostic imaging system for
radiographic and fluoroscopic studies.
Model Number: 10502200
Code Information 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
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer 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
FDA Determined
Cause 2		 Software design
Action ***UPDATE*** Siemens issued Urgent Medical Device Correction letter (expansion) via CSAN XP056/22/S to affected customers on 2/24/2023. The CSAN alerts the users to the issue warning them to pay special attention to the travel range of system parts. The CSAN urges users to stop system movement to prevent collision by releasing the movement control or by activating the emergency stop button as described in the system Operator Manual. Field corrective action via XP057/22/S will initiate an onsite visit to the customer facilities by a Siemens Customer Service Engineer to check the room configuration parameters current set on the systems and, if necessary, restore them to the correct values. This service will be provided to the customers free of charge. Customers with software version VF11 will be addressed under a separate and to be determined UI (update to VF11H). If you have any technical questions or desire an earlier appointment, please contact our service organization at 1-800-888-7436. _______________________________ ___________________________________________ Siemens Medical Solutions issued Customer Safety Advisory Notification( CSAN XP053/22/S) beginning on December 21, 2022. Letter states reason for recall, health risk and action to take: When performing unit movements, the user should pay special attention to the travel range of the system parts and stop movement in time to prevent a collision with the ceiling, wall, or objects. System movement can be stopped by releasing the movement control or by activating the emergency stop button as described in the system Operator Manual. Customer Safety Advisory Notice (XP053/22/S) will be distributed to all affected customers. Field corrective action via XP054/22/S will initiate an onsite visit of a Siemens Customer Service Engineer to check the room configuration parameters currently set for your system and if necessary, restore them to the correct values. These visits will be free of charge. The Siemens Service Or
Quantity in Commerce 4 units. Expanded Recall: 93 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
-
-