Recall record at a glance
| Official record | Z-1261-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Report date | Apr 4, 2018 |
| Recall initiation date | Jan 10, 2018 |
| Quantity | 165 units |
| Location | Malvern, PA, United States |
Official product description
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
Why the product was recalled
When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
Distribution information
Medical device software which needs to be installed.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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