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U.S. Department of Health and Human Services

Class 2 Device Recall 3mensio Workstation

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 Class 2 Device Recall 3mensio Workstationsee related information
Date Initiated by FirmJuly 14, 2025
Date PostedAugust 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2297-2025
Recall Event ID 97307
510(K)NumberK153736 
Product Classification System, image processing, radiological - Product Code LLZ
Product3mensio Workstation (Vascular Fenestrated) software
Code Information Software Version/UDI/Software Release Date: 10.6/(01)08056304455505(11)240325(8012)10.6/05-Apr-24, 10.7/(01)08056304455925(11)250423(8012)10.7/29-Apr-25, Service Packs/UDI: 10.6 SP1/(01)08056304455505(11)240411(8012)10.6 SP1/23-Apr-24, 10.6 SP2/(01)08056304455505(11)240610(8012)10.6 SP2/17-Jun-24, 10.6 SP3/(01)08056304455505(11)240926(8012)10.6 SP3/03-Oct-24, 10.6 SP4/(01)08056304455505(11)250109(8012)10.6 SP4/20-Jan-25, 10.7 SP1/(01)08056304455925(11)250523(8012)10.7 SP1/28-May-25
FEI Number 3003595527
Recalling Firm/
Manufacturer		 PIE Medical Imaging B.V.
Demertdwarsstraat 8A01
Maastricht Netherlands
For Additional Information Contact
31 433281328
Manufacturer Reason
for Recall		When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage
FDA Determined
Cause 2		Software change control
ActionOn 7/14/2025, correction notices were mailed and emailed to customers who were asked to do the following: When using software version 10.6, in case you open a session state with saved clock measurements and there is a need to adjust the 12h position for the clock positions, make sure to update all individual clock measurements in the perpendicular plane by the following steps: 1. Click on the clock position. 2. Update the 12h pointer of the clock in the perpendicular viewport. 3. Perform step 1 and 2 for all clock measurements in the analysis. After updating all 12h pointers, the information shown in the fenestration diagram is correct and functionality is restored. - Pass and post this notice for all who need to be aware within your organization or to any organization where the potentially affected product is in use. - Complete and return the Customer Acknowledgement Form via email to vigilance@pie.nl Questions can be sent to the above email. Firm will reach out to all customers to provide a link for the software installation.
Quantity in Commerce501
DistributionUS Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
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 = LLZ
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