Siemens PACS Software Recall for Incorrect Distance Measurements
Siemens Medical Solutions is recalling 49 PACS systems because they may display incorrect distance measurements when used with certain modalities and syngo Imaging.
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 source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 49 Picture Archiving and Communication System (PACS) units, identified by Model # 10014063. These systems are intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including digital mammography images.
The recall is being conducted to inform users about the possibility of incorrect values for distance measurements when using certain modalities in combination with syngo Imaging. The affected units were distributed nationwide in the United States, including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.
Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the potential measurement errors.
The recalled product
- Product
- A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 49
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 (1)
- Model # 10014063
Distribution
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