Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicat
FDA device recall Z-1643-2008 · posted 2008-08-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.
- Action taken
- The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions IM011/08/S. The letter informs customers of the potential issue and provides instructions to detect its occurrence. A software update to correct the issue is already available. A service representative will visit affected sites to install the software update. If you have questions concerning the advisory letter or you did not receive a letter contact Alexander Vogel at +49 (9131) 84-3840 or alexander.vogel@siemens,com and make reference to complaint 08-1KM-0073 date 2008-03-06.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 236 units
- Distribution
- The product was shipped to medical facilities in AL, AZ, CA, CO, CT, FL, GA, IA, KS, KY, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, WI, and WV.
- Date initiated
- 2008-03-10
- Date posted
- 2008-08-24
- Date terminated
- 2008-11-19
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING (VERSION V30) (K071114) | Siemens AG Medical Solutions | 2007-05-22 |