FDA Medical Device Recalls (openFDA)
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 number
- Z-1172-06
- Recalling firm
- General Electric Med. Sys. Ultrasound
- 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.
- Status
- Terminated
- Initiated
- 2006-02-24
- Posted
- 2006-06-27
- Terminated
- 2007-01-06
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 3,936 (969 US and 2,967 OUS)
- Distribution
- Nationwide, Puerto Rico and OUS to include: Algeria, Argentina, Austria, Belgium, Bosnia and Herzegovina, Brazil, Republic of Bulgaria, Byelorussian SSR, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, DVU Australia, Ecuador, Egypt, Finland, France, Federal Republic of Germany, Greece, Hong Kong, Republic of Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Kuwait, Republic of Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Kingdom of Saudi Arabia, Singapore, Republic of Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Yemen, Yugoslavia
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K041688"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 1000116747
- Firm city
- West Milwaukee
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28