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 Uroskop Omnia Max

  • 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 Uroskop Omnia Max see related information
Date Initiated by Firm December 21, 2022
Date Posted February 23, 2023
Recall Status1 Open3, Classified
Recall Number Z-1168-2023
Recall Event ID 91649
510(K)Number K173639  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for
radiographic and fluoroscopic studie
Model Number:10762473
Code Information UDI: 4056869008981 S/N: 4645 4556 4510 5144 4307 4594 4125 Expanded Recall 2/24/23: 4014 4015 4020 4022 4032 4033 4042 4047 4055 4059 4061 4062 4063 4067 4068 4086 4094 4096 4099 4102 4105 4106 4108 4111 4112 4114 4117 4119 4120 4126 4128 4129 4130 4132 4134 4135 4136 4141 4142 4146 4303 4305 4306 4310 4312 4314 4316 4318 4319 4325 4326 4329 4330 4332 4500 4501 4509 4513 4516 4519 4520 4529 4531 4532 4535 4537 4538 4540 4541 4543 4544 4548 4552 4553 4554 4557 4559 4561 4562 4565 4566 4570 4575 4580 4582 4585 4587 4588 4591 4593 4597 4600 4601 4602 4603 4605 4609 4616 4626 4627 4629 4630 4631 4635 4636 4637 4641 4651 4659 4660 5026 5028 5030 5031 5033 5049 5051 5061 5062 5064 5066 5069 5072 5074 5078 5084 5088 5093 5101 5103 5107 5108 5112 5114 5116 5118 5123 5124 5128 5130 5133 5134 5135 5137 5139 5140 5142 5146 5152 5159 5163 5173 5174 5175 5186 5187 5190 5191 5196 5197 5198 5199 5208 5215 5221 5222 5232 5240 5258 5267 5268 5278 6013 6021 6023 6034 6035 6038 6039 6043 6044 6048 6050 6054 6062 6064 6065 6066 6069 6072 6078 6079 6080 6085 6090 6091 6096 6113 6120 6121 6127 6129 6131 6134 6136 6141 6146 6149 6154 6157 6163 6165 6168 6169 6176
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 7 units; Exanded recall: 215 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, Inc
-
-