Siemens Syngo.plaza PACS Software Recalled for Data Security and Integrity Issues
Siemens Medical Solutions is recalling 47 units of Syngo.plaza PACS software to fix data loss, study mix-ups, and unauthorized access risks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with issues including unauthorized data access and study mix-ups, which pose a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 47 units of the Syngo.plaza Picture Archiving and Communication System (PACS) software, version VB20A. The affected model numbers are 10863171, 10863172, and 10863173. This software is used to display, process, and store digital medical images to support diagnosis and treatment planning.
The recall is being conducted to correct several software issues, including potential data loss, study mix-ups, incorrect measurements on multi-frame images, dearchiving issues, and unauthorized access to data due to inadequate permissions for shared folders.
The devices were distributed nationwide in the United States to the states of AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, and WI. No foreign consignees were reported. Users of this software should contact Siemens Medical Solutions USA, Inc. for information regarding the software update.
The recalled product
- Product
- Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, di
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 47
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 (4)
- Syngo.plaza with software version VB20A
- Model numbers: 10863171
- 10863172
- 10863173
Distribution
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