Siemens Medical Solutions Recalls Syngo.plaza PACS Software for Print Size Errors
Siemens Medical Solutions is recalling 149 units of Syngo.plaza and syngo Imaging XS software because printouts may be in incorrect anatomical size, potentially influencing diagnostic decisions.
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 3/5 (High).
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 is classified as FDA Class II. The hazard involves incorrect anatomical print sizes that may influence diagnostic decisions and therapy, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 149 units of Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS software. These products are Picture Archiving and Communication Systems (PACS) intended to display, process, read, report, communicate, distribute, store, and archive digital medical images. The recall covers units distributed nationwide in the United States.
The recall is due to a defect where printouts may be printed in incorrect anatomical size when using the syngo.plaza or syngo Imaging XS filming application with a printer not released for anatomical print usage. This issue can occur due to an invalid combination of the printer and the syngo.plaza printer configuration file. Incorrect anatomical sizes on printouts may influence diagnostic decisions and/or therapy.
The affected units are identified by specific model numbers and serial numbers listed in the recall documentation. Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to resolve the configuration issue and ensure correct printout sizes.
The recalled product
- Product
- Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 149
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 (20)
- model numbers: 10592457
- 10863171
- 10863172
- 10863173
- 7502029
- 10496279
- with multiple serial numbers: 1187
- 3182
- 3183
- 3212
- 3206
- 3207
- 1361
- 10870
- 12068
- 10733
- 3052
- 2323
- 1496
- 3246
Distribution
Distributed nationwide across the United States.
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