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 Symbia Pro.specta Q3, Symbia Pro.specta X3, and Symbia Pro.specta X7

  • 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 Symbia Pro.specta Q3, Symbia Pro.specta X3, and Symbia Pro.specta X7 see related information
Date Initiated by Firm July 12, 2023
Date Posted July 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2256-2023
Recall Event ID 92704
510(K)Number K212604  
Product Classification System, tomography, computed, emission - Product Code KPS
Product The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
Code Information Software version VA20A. (a) Serial numbers 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100209, 100208, 100210, 100212, 100211, 100213, 100215, 100217, 100219, 100218, 100220, 100221, and 100224; UDI-DI 4056869264745. Additional serial numbers as of 09/07/2023: 100223, 100225, 100227, 100228, 100237. (b) Serial numbers 100101, 100102, 100201, 100203, 100204, 100207, 100206, 100208, 100205, 100209, 100210, 100212, 100213, 100214, 100215, 100216, 100218, 100217, 100219, 100220, 100221, 100223, 100224, 100222, 100226, 100228, 100227, 100225, 100229, 100231, 100232, 100233, 100235, 100234, 100237, 100239, 100241, 100240, 100236, 100238, 100242, 100243, 100247, 100244, 100250, 100251, 100252, and 100255; UDI-DI 4056869264752; Additional serial numbers as of 09/07/2023: 100245, 100256, 100257, 100258, 100261, 100262, 100265, 100273. (c) Serial numbers 100101, 100201, 100203, 100202, 100205, and 100206; UDI-DI 4056869264769; Additional serial numbers as of 09/07/2023: 100208, 100210.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates IL 60192-2061
For Additional Information Contact Laura Meyer
847-217-2734
Manufacturer Reason
for Recall		 During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.
FDA Determined
Cause 2		 Device Design
Action The firm issued undated letters flagged Customer Safety Advisory Notice CAN 001-2023 on 7/12/2023 via email, certified mail, or, if necessary, hand delivery. The letter explains the issue, when the malfunction occurs, the potential risks, and how the consignee can help to avoid the potential risk of the issue. The letter informs the consignee that Siemens Healthineers is working to address the issue through a scheduled service visit and the consignee's local service organization will begin contacting the consignees in the 4th quarter of 2023 to schedule this work. In the meantime, the notice is to be placed in the Symbia Pro.specta Operator Manual and disseminated to all operators of the scanner. No response form was enclosed. The recalling firm uses an SAP system for tracking purposes. For the letters that are delivered via email, the consignee verifies receipt through an adobe signature. For the letters delivered via certified mail, there is a return receipt.
Quantity in Commerce 84 systems
Distribution Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
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 = KPS and Original Applicant = Siemens Medical Solutions USA, Inc.
-
-