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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 FirmMay 07, 2026
Date PostedJuly 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2767-2026
Recall Event ID 98930
510(K)NumberK250330 
Product Classification Automated Radiological Image Processing Software - Product Code QIH
Product3mensio Workstation (Vascular Fenestrated) software
Code Information Software Version 10.7. UDIs: (01)08056304455925(11)250423(8012)10.7, (01)08056304455925(11)250523(8012)10.7 SP1, (01)08056304455925(11)250714(8012)10.7 SP2, (01)08056304455925(11)250729(8012)10.7 SP3, (01)08056304455925(11)251016(8012)10.7 SP4, (01)08056304455925(11)251103(8012)10.7 SP5
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		User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information
FDA Determined
Cause 2		Software change control
ActionOn 5/7/2026, correction notices were emailed to customers who were asked to do the following: 1) Do not perform measurements on Philips 3D echo datasets containing the doppler information using 3mensio Workstation 10.7, 10.7 SP1 SP5. 2) Ensure that this notice is distributed to all relevant personnel within your organization and to any organization where the affected product may have been transferred to or is in use. 3) PMI recommends follow-up to verify if results of ordered devices are correctly analyzed/calculated. 4) Complete and return the enclosed Customer Acknowledgment Form and return via email to vigilance@pie.nl This issue has been resolved in 3mensio Workstation 10.7 SP6. PMI will support users in upgrading to this version.
Quantity in Commerce165
DistributionWorldwide - US Nationwide distribution in the states of CA, NY, MN, MI, TX and the countries of United Kingdom, Australia, France, Italy, Hong Kong SAR, Thailand, Taiwan, Netherlands, Ireland, Spain, Greece, Japan, Belgium.
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 = QIH
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