Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 514287
FDA device recall Z-2312-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.
- Action taken
- Consignees were sent a GE "Urgent Field Safety Notice" letter dated March 13, 2008 addressed to Hospital Administrators; Managers of Radiology/Cardiology; Radiologists/Cardiologists on May 2008. The letter described the safety issue, affected product, product correction, safety instructions and contact information. A GE Field Engineer to visit site to implement the correction (FMI No. 25409). Contact information: 800-437-1171 (USA); 0120-055-919 (Japan); 0800-15-25-25 (France); for all other countries contact your local GE Healthcare sales or field representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 5,249 (2,104 US/ 3,145 OUS)
- Distribution
- AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Algeria Argentina Australia Austria Belgium Bosnia Br
- Date initiated
- 2008-05-01
- Date posted
- 2008-09-20
- Date terminated
- 2011-12-11
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VOLUME VIEWER PLUS (K041521) | General Electric Medical Systems | 2004-06-22 |