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
FDA device recall Z-1172-06 · posted 2006-06-27 · Terminated
Recall details
- Recalling firm
- General Electric Med. Sys. Ultrasound
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 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
- Date initiated
- 2006-02-24
- Date posted
- 2006-06-27
- Date terminated
- 2007-01-06
- Location
- West Milwaukee, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 (K041688) | General Electric Co. | 2004-07-08 |