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 Catalyst() FAMILY

  • 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 Catalyst() FAMILYsee related information
Date Initiated by FirmApril 22, 2025
Date PostedMay 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1858-2025
Recall Event ID 96791
510(K)NumberK200435 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductBrand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component
Code Information All Catalyst products using software Version: c4D 6.5.1 SP2 Catalyst -SP001-0025/UDI: 07350005280024; Catalyst HD- SP001-0026/UDI: 07350005280024; Catalyst PT- SP001-0027/UDI: 07350005280024; Catalyst X4- SP002-0035/UDI: 07350005280024; Catalyst+ - REF: SP003-0001/UDI: 17350005280762 Catalyst+ HD- SP003-0002/UDI: 17350005280779 Catalyst+ PT- SP003-0008/UDI: 17350005280793 Catalyst+ X4 - SP003-0009/UDI: 17350005280809
Recalling Firm/
Manufacturer		 C-RAD POSITIONING AB
Bredgrand 18
Uppsala Sweden
For Additional Information ContactPeter Nyman
561-271-3390
Manufacturer Reason
for Recall		Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
FDA Determined
Cause 2		Software design
ActionOn April 22, 2025, C-RAD Positioning AB issued a Field Safety Notice to affected consignees via E-Mail. C-RAD asked consignees to take the following actions: 1. As an immediate action, the affected users are recommended to: - Do not use Site Groups for treatment plans containing non-coplanar fields. - Ungroup all existing Site Groups. 2. Ensure that all the staff operating the Catalyst family systems and the c4D software application are aware of this information. 3. All customers are requested to reply to C-RAD using the attached FSN Customer Reply Form .
Quantity in Commerce44 units
DistributionWorldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, Belgium, Uzbekistan.
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 = IYE
-
-