3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements
PIE Medical Imaging B.V. is recalling 3mensio Workstation (Vascular Fenestrated) software because it may provide inaccurate cardiovascular measurements under specific conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device software where inaccurate measurements could lead to harm, though no injuries have been reported in the source text.
Plain-English summary
PIE Medical Imaging B.V. has issued a recall for 3mensio Workstation (Vascular Fenestrated) software. The software is intended to measure and visualize cardiovascular structures.
Users may encounter measurement errors where reported values are larger than actual anatomical dimensions by 0.8% to 34.4%. This error occurs only if the software is used with 3D Echo or Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information.
The affected software versions include 10.7 and its subsequent service packs (SP1 through SP5). This recall affects 165 units distributed worldwide, including in the United States (CA, NY, MN, MI, TX), the United Kingdom, Australia, France, Italy, Hong Kong SAR, Thailand, Taiwan, Netherlands, Ireland, Spain, Greece, Japan, and Belgium.
The recalled product
- Product
- 3mensio Workstation (Vascular Fenestrated) software
- Manufacturer
- PIE Medical Imaging B.V.
- Hazard
- Affected units
- 165
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
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