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 Optima URS by Sedecal SA

  • 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 Optima URS by Sedecal SAsee related information
Date Initiated by FirmDecember 13, 2023
Date PostedJanuary 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0781-2024
Recall Event ID 93614
510(K)NumberK012546 
Product Classification System, x-ray, stationary - Product Code KPR
ProductSedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
Code Information All serial numbers, UDI-DI 08436046002500.
Recalling Firm/
Manufacturer		 SEDECAL SA
PELAYA, 9 POL.
POL. IND. RIO DE JANEIRO
Algete Spain
For Additional Information ContactDevan Moser
847-394-6960
Manufacturer Reason
for Recall		Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
FDA Determined
Cause 2		Equipment maintenance
ActionOn 12/13/2023, the recalling firm emailed the recall letter dated 12/11/2023 to their distributor customers along with attachments for service and maintenance of the units. The letter explained a description of the issue and that the installed devices should be inspected to ensure they are being used in a safe mode (the unit has been properly maintained and does not show any signs of the screws loosening) and to fix any potential issues. This inspection will also be included in all scheduled maintenance tasks to be performed in the future. The letter is to be distributed to all staff involved. The letter included 3 attachments. Annex 1 contains further information regarding the issue. Annex 2 is the acknowledgement of receipt of the notification and understanding of the described problem and its importance. Annex 3 is confirmation that the mandatory field checks or upgrade of the affected unit is complete. The firm reported distributors will provide the information to the medical facility either by using the recalling firm's letter or creating a new letter.
Quantity in Commerce845 units
DistributionDistribution was made to AL, FL, and NC. There was no military/government distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPR
-
-