software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, displ
FDA device recall Z-0826-2016 · posted 2016-02-19 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
- Action taken
- The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2019 to its customers.The notice described the product, problem and actions to be taken. The customers were instructed to create a new department if immediate resolution is necessary, use workplace for reporting and hand over the customer letter before or during installation of field modification(PSL) distributed with Update Instruction SY013/16P. A software update to resolve reported issues is being released via an Update Instruction SY013/16/P. If you have any questions, contact Regulatory Technical Specialist at 610-448-6478 or email: anastasia.sokolova@siemens.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 151
- Distribution
- US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.
- Date initiated
- 2016-01-29
- Date posted
- 2016-02-19
- Date terminated
- 2017-02-16
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO DYNAMICS, VERSION 9.0 (K102150) | Siemens Medical Solutions USA, Inc. | 2010-10-05 |
| KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K023772) | Acuson Corp. | 2002-11-22 |