General Electric Med. Sys. Ultrasound Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system.
Brand
General Electric Med. Sys. Ultrasound
Lot Codes / Batch Numbers
Software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. Serial number ranges A06251 thru A09914
Products Sold
Software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. Serial number ranges A06251 thru A09914, A12012 thru A31198 and A35001 thru 35097 may include devices that are not subject to the correction. Serial number ranges A10000 thru A11087 and A31201 thru A33742 only include devices subject to the correction
General Electric Med. Sys. Ultrasound is recalling Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4. due to In the cardiac measurement section of the device the calculation of the 'PG Mean' (mean pressure gradient) leads to an erroneous result. It is recomm. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In the cardiac measurement section of the device the calculation of the 'PG Mean' (mean pressure gradient) leads to an erroneous result. It is recommended that customers with affected units do not use the measurement in question 'PG Mean' for any diagnostic or therapeutic decision, and 'PG Mean' values should not be included in any patient documentation.
Recommended Action
Per FDA guidance
An Urgent Medical Device Correction letter to customers 04/17/2006, states the product affected, provides a recommendation for affected units continued use until a software update is provided to the facility by a GE Healthcare Representative. Customers are recommended to not use the measurement in question 'PG Mean' for any diagnostic or therapeutic decision, and 'PG mean' values should not be included in any patient documentation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026