Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.
FDA device recall Z-0102-2009 · posted 2008-10-15 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Image may not be visible after merge.
- Action taken
- The recalling firm issued Customer Safety Advisory Notice dated 8/22/08 to inform the consignees of the potential issue and provide instruction to avoid its occurrence. To avoid potential risk of this issue, users are asked to check whether the extended HL7 messages as stated in the letter are mandatory for their RIS-PACS workflow, and disable these messages if they are not. Siemens is preparing a modification under the UI IM086/08/S for the affected versions of syngo Imaging that will resolve the potential malfunction. The field modification will be immediately distributed and installed by the firm's Service as soon as it is available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 59 units
- Distribution
- Nationwide Distribution --- including states of AL, AZ, CA, CO, CT, FL, IA, KS, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, TN, TX, and WI.
- Date initiated
- 2008-08-22
- Date posted
- 2008-10-15
- 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 |
| SYNGO IMAGING VERSION V20A (K052461) | Siemens AG Medical Solutions | 2005-09-22 |