GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that
FDA device recall Z-0125-2013 · posted 2012-10-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
- Action taken
- Consignees were sent on 5/24/12 a GE Healthcare "Urgent Medical Device Correction" letter dated May 23, 2012. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction. Customers should verify if their workstation is affected. GE Healthcare will correct all affected workstations by providing a software upgrade and Operator Manual update. A GE Healthcare service representative will contact you to arrange this correction. This activity will be performed at no cost to you. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 12
- Distribution
- Worldwide Distribution -- USA (nationwide) including states of: CA, CT, NY, TX, and MS and countries of TAIWAN, ITALY, CANADA, and BAHRAIN
- Date initiated
- 2012-05-24
- Date posted
- 2012-10-24
- Date terminated
- 2012-12-11
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENO ADVANTAGE (K033400) | Ge Medical Systems W-400 | 2003-12-04 |