3mensio Workstation recall: Software Issue
3mensio Workstation (Vascular Fenestrated) software
Why was 3mensio Workstation recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 3mensio Workstation (Vascular Fenestrated) software
- Recalling firm
- PIE Medical Imaging B.V.
- Quantity
- 501
- Distribution
- US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
- Recall date
- August 20, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)