Siemens Syngo.plaza PACS Recalled for Incomplete Archived Studies
Siemens Medical Solutions is recalling four Syngo.plaza PACS units because they may leave partially archived studies unarchived during pre-fetch operations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software defect leading to incomplete data archiving without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling four units of the Syngo.plaza Picture Archiving and Communication System (PACS). The device is intended to display, process, read, report, communicate, distribute, store, and archive digital medical images to support physician diagnosis and treatment planning.
The recall is due to a defect where, in a server farm setup, performing a pre-fetch or retrieve operation on partially archived studies may result in series that have not yet been archived remaining unarchived. This issue could lead to incomplete archived studies.
The affected units are distributed in Massachusetts, Wisconsin, and Florida. The specific model numbers are 10592457 and 10863172, with serial numbers 100177, 100033, 100181, and 100029. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving this issue.
The recalled product
- Product
- Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Numbers of device: 10592457
- 10863172
- serial numbers: 100177 100033 100181 100029
Distribution
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