GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno Advantage is a medical image r
FDA device recall Z-1747-2010 · posted 2010-06-02 · 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. When using the Print Image or Print Screen feature on SenoAdvantage 2.2, the Scale factor annotation printed on hard copy images is inaccurate. Secondary Capture (SCPT) images displayed on the screen and Secondary Capture hard copy images may a
- Action taken
- The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated February 8, 2010 to customers. The letter described the Safety Issue, Affected product details, Safety Instructions to prevent further inaccurate scale factor annotation, Product Correction and Contact Information. GE Healthcare will correct all affected workstations by providing a software upgrade and an updated Operator Manual. The GE service representative will contact customer to arrange for this correction. 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
- 73 devices
- Distribution
- Worldwide distribution: USA including states of CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX and countries of THAILAND, TAIWAN, SWEDEN SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, PAKISTAN, MEXICO, JA
- Date initiated
- 2010-02-09
- Date posted
- 2010-06-02
- Date terminated
- 2011-12-18
- 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 |