Recall Z-1172-06 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
| Date | Jun 27, 2006 (initiated Feb 24, 2006) |
| Status | Terminated |
| 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, H |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041688 | GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 General Electric Co., Jul 8, 2004 |